Monica Rita Hendricks PDF

A Study to assess the effectiveness of soya bean on menopausal symptoms among
women working in St. John’s National Academy of Health Sciences– Bangalore
By
Ms. Monica Rita Hendricks
Dissertation submitted to the
Rajiv Gandhi University of Health Science, Karnataka, Bangalore.
In partial fulfilment
of the requirements for the degree of
Master of Science in Nursing
in
OBSTETRICS AND GYNAECOLOGICAL NURSING
Under the guidance of
Sr. Mariam O J (Sr. Celcy Mary)
Associate Professor
Department of obstetrics and gynaecological nursing
St. John’s College of nursing
St. John’s National Academy of Health Sciences
Bangalore- 560034
Karnataka
2013
i
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA
DECLARATION BY THE CANDIDATE
I hereby declare that this dissertation/ thesis entitled “A Study to assess the
effectiveness of soya bean on menopausal symptoms among women working in
St. John’s National Academy of Health Sciences– Bangalore” is a bonafide and
genuine research work carried out by me under the guidance of Sr. Mariam O J,
Associate Professor, Department of Obstetrics and Gynaecological Nursing, St.
John’s College of Nursing, Bangalore.
Reg. No: 11NO267 Monica Rita Hendricks
Date: MSc Nursing
Place: Bangalore St. John’s College of Nursing
Bangalore
ii
CERTIFICATE BY THE GUIDE
This is to certify that the dissertation entitled “A Study to assess the effectiveness of
soya bean on menopausal symptoms among women working in St. John’s
National Academy of Health Sciences– Bangalore” is a bonafide research work
done by Monica Rita Hendricks in partial fulfilment of the requirement for the
degree of Master of Science in Nursing.
Date: Signature of the guide
Place: Bangalore Sr. Mariam O J (Sr. Celcy Mary)
Associate Professor
Department of OBG Nursing
St. John’s College of Nursing
Bangalore
iii
CERTIFICATE BY THE CO-GUIDE
Date: Signature of the Co- Guide
Place: Bangalore Dr. Rita Mhaskar
Professor
Department of OBG
SJMCH
Bangalore.
iv
ENDORSEMENT BY THE H. O. D, PRINCIPAL/ HEAD OF THE
INSTITUTION
Seal & Signature of the HOD Seal & signature of the Principal
Sr. Mariam O J (Sr. Celcy Mary) Mrs. Madonna Britto
Date: Date:
Place: Bangalore Place: Bangalore
v
COPYRIGHT
Declaration by the candidate
I hereby declare that Rajiv Gandhi University of Health Sciences, Karnataka shall
have the rights to preserve, use and disseminate this dissertation/ thesis in print or
electronic format for academic/ research purpose.
Date: Signature of the candidate
Place: Bangalore Monica Rita Hendricks
© Rajiv Gandhi University of Health Sciences, Karnataka
vi
ACKNOWLEDEGEMENT
“My grace is sufficient for thee: for my strength is made perfect in weakness”
2Cor. 12:9
I thank God almighty for his fathomless love and grace which strengthened and
sustained me throughout this endeavour.
I wish to express my sincere appreciation and deep gratitude to all those who helped
me in accomplishing this task successfully.
Sr. Mariam O J (Sr. Celcy Mary) Associate Professor, Department of Obstetrics
and Gynaecological Nursing, St. John’s College of Nursing. I express my heartfelt
gratitude to my teacher and guide for her concern, scholastic guidance and valuable
suggestions in nurturing a true spirit of research. Her invaluable contributions
transformed my work and gave precision to this manuscript.
Dr. Rita Mhaskar M D, Professor, Department of Obstetrics and Gynaecologyfor
her expert advice, guidance, suggestions, encouragement and willingness to spend her
time for me with cheerfulness amidst her busy schedule.
I extend my deep rooted thanks to Prof. Madonna Britto, The Principal, St. John’s
College of Nursing for having provided the necessary facilities and constant support,
guidance and encouragement to ensure best quality in this piece of work.
Special thanks to Prof. Mercy P. J, M. Sc. Co-ordinator, Prof. Mary Ann
Washington, for their prayers, concern, guidance, understanding andencouragement
in this study.
vii
I thank Rev. Dr. Lawrence D’ souza, Director,Rev. Fr. Immanuel, Associate
director, Sr. Lizy Poonolil, Nursing Superintendent, for providing me the
opportunity to undertake this study.
My in depth gratitude to Mrs. Salomi Thomas, Associate Professor, Dr. Priyanka
Rohatgi, Chief Clinical Nutritionist- Apollo hospitals for their valuable time,
support and who have gone the extra mile to help me in this endeavour.
My heartfelt gratitude to the entire MSc. Faculty, for theirvaluable contribution to this
study
Genuine thanks to Mr. Jeeva, Mrs. Sumithra for their irreplaceable support in data
analysis
My sincere gratitude to Mrs.Veena, for her culinary expertise and timely help
I pay my gratitude to Mrs. Siromony Nirmala Rani, P G English, Sacred Heart
Convent HSS Villipuram for editing my manuscript.
My heartfelt thanks to my parents, sister and all my friends far and nearfor their love,
prayers, support and encouragement.
I express my warm thanks to Sr. Roopa and Sr. Diana, housekeeping in charges
and Mrs. Rajalakshmi and Mrs. Nirmala, librarians for their constant and
unfailing support all through my study.
I express my gratitude to all the women who participated in this study. I pay my
thanks to all my classmates for their timely help and support
Date: Signature of the candidate
Place: Bangalore Monica Rita Hendricks
viii
LIST OF ABBREVATIONS USED
1. HRT : Hormone Replacement Therapy
2. BMI : Body Mass Index
3. NIH : National Institute of health
4. NCCAM : National Centre for Complementary
and Alternative Medicine
5. OPD : Out Patient Department
6. RCT : Randomized controlled trial
7. CEE : Conjugated Equine estrogen
8. MPA : Medroxyprogesterone Acetate
9. MBSRQ : Multidimensional body- self relations
Questionnaire
10. FSH : Follicle stimulating hormone
11. LH : Luteinizing hormone
12. HDL : High density lipoprotein
13. LDL : Low density lipoprotein
14. TLC : Therapeutic lifestyle changes
15. CT : Computed tomography
16. ANOVA : Analysis of variance
ix
ABSTRACT
Background
Menopause is a natural life event in every woman’s life and the experience is
uniquely individualized. Many women have a positive response, whereas some
women feel battered. The only way to curb this problem is to supplement the
declining hormones in the woman’s body. The synthetic ones are considered
unnatural and pose the woman to numerous side effects11, which makes many women
to turn to earth’s natural healing miracles to help them cope.
The purpose of the present study was to assess the effectiveness of soya bean on
menopausal symptoms among women working in St. John’s National Academy of
Health Sciences– Bangalore.
Objectives of the study
1. To compare the menopausal symptoms before and after the intervention in
experimental and control group
2. To determine the association between menopausal symptoms before intervention
with baseline variables
x
Methods
The research design adopted for the present study was an experimental study design.
The setting was St. John’s National Academy of Health Sciences – Bangalore. Using
simple random sampling technique, forty menopausal women who met the inclusion
criteria were selected for the study. Ethical clearance was taken from the institutional
ethical review board. The purpose of the study was explained and a written consent
was taken from the participants. Participants were randomly allocated to the control
and experimental group using a statistical software. A structured interview schedule
was used to assess the prevalence, the baseline variables and also the Wiklund
menopausal symptom scale. The soya bean laddu (25 gram) was administered to the
experimental group and the rice laddu ( 25 gram ) to the control group for a period of
thirty days. The participants were again asked to rate the scale on the fifteenth day and
on the thirtieth day.
The data was analysed using descriptive and inferential statistics.
Results
The mean/SD of the post test scores in the experimental group was 29.50±14.42,
whereas the mid-test score was 31.15±15.22, which was significantly lesser than the
pre-test score 46.00±13.64 and the level of significance of the change was 0.02 for
mid-test and 0.01 for the post-test scores in the experimental group in comparison
with the control group.
xi
Conclusion:
By helping women through these tough years, health professionals could help them
feel that they could still exert some control over their health and make them feel
confident and trust their health care personnel.
Key words: menopause, menopausal symptoms, soya isoflavnones.
xii
TABLE OF CONTENTS
Chapter No. Contents Page No.
1. Introduction 1-8
2. Objectives 9-17
3. Review of Literature 18-40
4. Research methodology 41-49
5. Results 50-67
6. Discussion 68-76
7. Conclusion 77-84
8. Summary 85-87
9. Bibliography 88-95
10. Annexure 96-123
xiii
LIST OF TABLES
Sl. No. Table Page
no.
Table 1a Distribution of participants according to duration of menopause, 51
education, occupation and marital status of women with
menopausal symptoms
Table 1b Distribution of participants according to support system, 52
alternative system of medicine practice, type of menopause and
BMI of women with menopausal symptoms
Table 2 Range, mean, standard deviation of pre, during and post test 53
scores of menopausal women in control and experimental group
Table 3 Findings related to the association between menopausal 67
symptoms and selected baseline variables
xiv
LIST OF FIGURES
Sl. No Figure Page No.

Figure 1 Conceptual framework based on Imogene King 17
Figure 2 Schematic representation of the study design 42
Figure 3 Schematic representation of the research design 43
Figure 4 Findings of hot flashes before, during and after 54

the intervention in the experimental and control
group
Figure 5 Findings of sweats before, during and after the 55

intervention in the experimental and control
group
Figure 6 Findings of sleep disturbances before, during 56

and after the intervention in the experimental
and control group
Figure 7 Findings of fatigue before, during and after the 57

intervention in the experimental and control
group
Figure 8 Findings of vaginal dryness before, during and 58

after the intervention in the experimental and
control group
Figure 9 Findings of depression before, during and after 59

group
Figure 10 Findings of headache before, during and after 60

group
Figure 11 Findings of irritability before, during and after 61

group
Figure 12 Findings of muscle/ joint pain before, during 62

and after the intervention in the experimental
and control groups
xv
LIST OF FIGURES
Sl. No. Figure Page
No.
Figure 13 Findings of nervousness before, during and after the intervention 63
in the experimental and control groups
Figure 14 Findings of palpitations before, during and after the intervention 64
in the experimental and control groups
Figure 15 Findings of dizziness before, during and after the intervention in 65
the experimental and control groups
Figure 16 Findings of breast tenderness before, during and after the 66
intervention in the experimental and control groups
xvi
LIST OF ANNEXURES
Sl. No. Table Page

no.
1 Letter to the Director seeking and granting permission to conduct the 96-100
study
2 Letter seeking IERB (Institutional Ethical Review Board) approval 101
3 Certificate of IERB ( Institutional Ethical Review Board) approval 102
4 Certificate of clearance from nutritionist 103-105
5 Letter seeking expert opinion on editing the research thesis 106
107
6 Certificate of editing
7 Patient Information sheet 108
8 Informed consent 109
9 Tool for data collection- English and Tamil 110-118
10 Certificate of translation 119
11 Certificate of validation for kitchen weighing scale 120
12 Certificate of validation of weighing scale

121
13 Letters from international experts 122-123
xvii
1. INTRODUCTION
The joy of menopause is the world’ s best kept secret… in order to claim that joy a
woman must be willing to pass beyond the monsters who guard its gate. As you stand
at the brink of it, it can appear that only darkness, danger and decay lie beyond. .but..
As thousands of women from all cultures throughout history have whispered to each
other it is the most exciting passage a woman ever makes.
Menopause and beyond- the wise woman way!! The wise woman tradition seeks to
heal the whole individual. The primary technique involves nourishing the woman
through story- telling, simple ceremony and dietary herbs. The mysteries of a
woman’s body- puberty, menarche, pregnancy, lactation and menopause are seen as
times of power and growth. Menopause is an opportunity for conscious change, not a
disease to be treated1.
Menopause is a discrete event- the last menstrual period – with a retrospective
diagnosis requiring twelve months of amenorrhea to be certain, it has occurred. Every
woman who lives long enough will become menopausal as part of the ageing process,
but ageing is not the only pathway to menopause. Induced menopause occurs with
surgical removal of both ovaries or with cessation of ovarian function by
chemotherapy or radiation. With induced menopause, particularly oophorectomy, the
symptoms of menopause occur immediately and are often more pronounced than in
age-induced menopause. Even if ovaries are untouched during hysterectomy,
menopause occurs, the symptoms and health risks associated with falling estrogen
levels are common concerns for all women.
1
Menopause is genetically predetermined. A woman is born with approximately two
million primary follicles; by the onset of puberty, approximately 400,000 of follicles
remain in the ovaries, out of these some 400 are likely to ovulate during the entire
reproductive period. During the next 30 or so years, between puberty and menopause,
those follicles will either mature into eggs or disintegrate. The number of follicles
decreases sharply after a woman reaches 40. With this decrease, follicle-stimulating
hormone levels increase significantly to stimulate a follicle to ripen an egg. Because
the production of estradiol occurs with follicle maturation, the amount of estradiol is
greatly decreased and continues to decline until it’ s sufficient to cause the build – up
of the endometrial levels. Eventually, uterine bleeding ceases and the woman is
clinically termed menopausal2.
The term menopause is derived from the Greek word “meno” (month or menses) and
“pause” which refers to cessation, therefore cessation of menses. Currently,
practioners view menopause as a unique stage within the continuum of health stages
of a woman rather than a disease. This change of life is a natural process- in fact, the
decline and cessation of ovarian function constitutes an entire period of a woman’ s
life that lasts approximately 6 to 13 years. Women transitioning from perimenopause
to post menopause experience a host of hormonal changes. The declining levels of
estrogen that accompany the perimenopausal years and the subsequent loss of estrogen
that accompanies menopause may place the woman at risk for numerous physiologic
alterations. Typically, the symptoms of hot flashes/flushes, night sweats and insomnia
frequently cause women to seek assistance from their health care providers3.
Menopause severely disrupts some women’s lives, but causes little or no disturbances
for others4. It’ s also at this stage of life that many women are counselled to begin a
hormone replacement therapy regimen because of the widely researched and well
2
documented protective benefits of HRT against cardiovascular disease and
osteoporosis. Health care providers and their practices can benefit from the wide range
of therapeutic options that are now available for helping women through menopause.
Among the current choices women have the options of pursuing traditional hormone,
or natural and/or alternative therapies. Women’s increased awareness and respect for
the wisdom of nature has created the need for alternative approaches within
individualized care during all phases of menopause. Alternative therapies are
numerous. The following list includes some of the popular approaches like diet,
exercise, lifestyle changes, stress management and relaxation techniques, biofeedback,
acupuncture, nutritional supplements, botanical therapy, natural hormone preparations,
‘friendlier’ conventional HRT. What’s important for practitioners is to hone their
knowledge and skills in working with natural and alternative therapies because women
are dabbling in these, often without counsel and direction from practitioners3.
Nurses are going to see women who are taking herbs and other alternatives, and who
may or may not tell their practitioners about their practices. But practitioners must at
least ask women and chart information they receive in medical records. As this
generation enters midlife, the symptoms and treatments related to menopause are
increasingly discussed and debated. There is also the underlying paradigm that the
stages of perimenopause are stages of transition along a woman’ s continuum of
lifetime health and wellbeing and as such, many women don’t want the natural
process treated as a disease. Rather, women want changes and treatment options that
make the transition from perimenopause to menopause4.
3
The soyabean – a legume- is a vegetable protein that contains zero cholesterol and is
low in saturated fat. Soyabeans are a great source of iron, B vitamins, calcium, zinc
and dietary fibre- on par with high- quality proteins found in milk, eggs and meat is
considered as an alternative option in the treatment of menopausal symptoms. A
number of biologically active components are in soya beans, including isoflavnones,
which are thought to possess weak estrogenic activity. The major isoflavnones are
genistein and daidzein, which are phytoestrogens. Setchell in a keynote address to the
second international symposium on “ the role of soy in preventing and treating chronic
disease,” stated that while there has been a veritable explosion of interest in
phytoestrogens, much of the current interest has focusses on compounds in the
isoflavnone class. Although isoflavnones are found in many plants, they are highly
concentrated in soyabeans5.
Additionally, the estrogenic effects of soy and a diet rich in soy have been studied for
menopausal women. Soy is responsible for dilator responses of atherosclerotic
coronary arteries to acetylcholine, and that genestein, one of the isoflavones, may be
an active component of soy. Alcohol – extractable components of soy protein are
apparently responsible for much of soy’s cardiovascular benefits. Women whose diets
are high in soy have significantly less breast cancer; soy phytoestrogens are as much
as ten times weaker than estradiol. Phytoestrogens compete with estradiol for binding
of estrogen receptor sites. Phytoestrogens have cancer preventive effects; soy has
inhibited tumour growth in animal studies. Three epidemiological trials have
demonstrated soybean’s protectiveness against breast cancer3.
4
The concept of the older woman as a granny in a rocking chair, wrapped in a shawl,
doesn’t fit anymore. In fact, it never was an accurate picture rather, a misleading
stereotype. Women of today are letting everyone know that there’s life after 50 and 60
and even older. It’s not fair to place a stereotypical standard on women as they age;
we must support our sisters no matter the circumstance. With a little help women in
and around the menopausal age could really embrace and enjoy life6.
5
NEED FOR THE STUDY
Menopause is a normal natural event, a change of life; usually confirmed when a
woman has missed her periods for 12 consecutive months (in the absence of other
obvious causes) 7. Menopause is defined as the permanent cessation of menstruation
resulting from loss of ovarian follicular activity8. During this transition a woman
experiences many changes which are normal consequences of both menopause and
ageing7. Some women may experience troublesome symptoms whereas others may
navigate the transition with few or even no symptoms at all 7. With increasing
longevity nearly 85% of women are spending more than one third of their lives in the
postmenopausal period and bear the consequence of this endocrine deficiency state8.
More than 12% of our population will be 60 or more by 20259. By the year 2020, 45.9
million women will be experiencing menopause10.
Despite an aggressive marketing, women are always reluctant to take estrogen
replacement therapy. Even in developed countries, only 35% of women started taking
estrogen replacement therapy and only 15 % continued it. Estrogen replacement
therapy was considered “unnatural“, as there were risks of breast and endometrial
cancer11.
Phytoestrogens on the other hand are natural products that offer the beneficial effects
of oestrogens minus their adverse effects. Epidemiological studies (observational)
revealed that rates of cardiovascular diseases and colon,prostate and breast cancers
were low in societies consuming high quantities of soy in their diets11.
6
Japanese women have a much lower incidence of hot flushes, as their diet is rich in
soya12,13. Phytoestrogens have been found to reduce vasomotor symptoms in most of
the epidemiological studies. One study found a 45% decrease in menopausal flushes
on women using 40-60 mg of soy products per day11. Phytoestrogens also have other
benefits, like improved vascular compliance by 26% is noted, they cause a favourable
alteration in insulin resistance, improves glycaemic control and serum lipoproteins are
altered favourably. They also have lowered the incidence of osteoarthritis and prevent
cardiac diseases in predisposed women11.
This natural therapy is more cost effective too. In India, about 19% women have hot
flushes13. Plants have been used as medicine since time immemorial, therefore
phytoestrogens (occurring naturally in certain food products) should not be set aside
as quackery, but should be studied more vigorously to further elaborate the efficacy on
human body14.
With the latest findings from Women‘s Health Initiative confirming what made
headline news in 2002- that hormone therapy is now more presumed harmful, than
potential benefit , particularly for women with or at a risk for cardiovascular disease or
cancer, therefore women are turning to alternative therapies to treat the signs and
symptoms of menopause15.
According to American College of Obstetrics and Gynaecology -2002 , when 10,000
women were on Hormone replacement therapy for one year, eight more of the women
will develop breast cancer, seven more of the women develop coronary events, eight
more will have pulmonary embolism , but six fewer will have colorectal cancer and
five fewer will have hip fractures16.
7
As not many studies are done in India in this area, there is a need for this study
especially as generally Indian women do not correlate these symptoms as being due to
menopause. Knowledge and scientific data on menopausal symptoms experienced by
Indian women is sparse12. In India most women take the minor symptoms like hot
flushes in their stride17.
In a study,conducted by Ginrich.P.M, Fogel.C.I, in the USA more than two thirds of
the women in the study used herbal therapy, out of which 77.5% got information from
books,62.5 % from family and friends ,one third from physicians and only 7.5 % from
registered nurses. Patients long for guidance, support and collaboration with their
health care providers in finding efficacious treatments for their symptoms.
Therefore advanced practice nurses and physicians should become knowledgeable
about evidence based herbal therapies and should be able to fully meet their patient’s
expectations and provide comprehensive care18.Soya bean is an alternative and
evidence based therapy.
Nurses must be prepared to offer extensive and unbiased information regarding
Hormone replacement therapy and alternative therapies18.It is therefore necessary to
stay abreast of new information, about the safety and efficacy of herbal and dietary
therapies, carefully eliciting herbal and dietary supplement use during history taking,
communicating effectively regarding the risks and benefits of these therapies, and also
to refer patients to reliable alternative therapy resources15
8
2. OBJECTIVES
STATEMENT OF THE PROBLEM
A Study to assess the effectiveness of soya bean on menopausal symptoms among
women working in St. John’s National Academy of Health Sciences– Bangalore
OBJECTIVES OF THE STUDY
OPERATIONAL DEFINITIONS:
Effectiveness
In this study it referred to the change in intensity of menopausal symptoms among
menopausal women before and after the consumption of soya bean measured by the
Wiklund menopausal symptom scale19. (annexure- 9).
Soyabean laddu
In this study it referred to eating of one 25 gram soya bean laddu by subjects of the
experimental group daily for a duration of 30 days. The soya beans were soaked
overnight (8 hours) and boiled for ten minutes and sun dried before use.
Each soya bean laddu was made of 25 grams of roasted coarse ground soya flour and
10 grams of jaggery.
9
25 grams of soya bean contained 108 kilo calories, 5.225 grams carbohydrate, 10.8
grams protein and 4.87 grams fat; 10 grams of jaggery contained 6.1 kilo calories and
1.52 gram carbohydrate and 32.59 mg of isoflavnone.
Each soyabean laddu would totally amount to 114.1 kilo calories, with 6.745 grams of
carbohydrate, 10.8 grams of protein and 4.87 gram of fat20,21( annexure 4).
Rice Laddu
In this study it referred to eating of one 25 gram rice laddu daily by subjects of the
control group for a duration of 30 days.
Each rice laddu was made of 25 grams of roasted coarse ground rice flour and
10grams of jaggery.
25 grams of milled raw rice contained 86.25 kilo calories, 19.725 grams of
carbohydrate, 1.725 grams of protein and 0.1gram of fat. 10 grams of jaggery
contained 6.1 kilo calories, 1.52grams of carbohydrate.
Each rice laddu would totally amount to 92.35 kilo calories, 21.245 grams of
carbohydrate, 1.725 grams of protein and 0.1gram of fat20, 21.
Menopausal Symptoms
In this study referred to 13 menopausal symptoms; sweats, hot flashes, sleep
disturbances, fatigue, vaginal dryness, depression, headache, irritability, muscle/ joint
pain, breast tenderness, nervousness, palpitations and dizziness/fainting rated for
severity subjectively by Wiklund menopausal symptom scale19.
10
Working Women
In this study referred to all working women in St. John‘s National Academy of Health
Sciences- Bangalore, presenting with two or more symptoms per day in the Wiklund
Menopausal symptom scale, persisting for the last one month19.
Menopausal Women
In this study referred to women with natural menopause (after 12 months of
amenorrhea) or surgical menopause (after six weeks have elapsed) presenting with
two or more symptoms per day in the Wiklund menopausal symptom scale, persisting
for the last one month19.
Baseline Variables
In this study referred to age, education, occupation, body mass index (BMI), marital
status, age at menopause and type of menopause (surgical / natural),Support system,
any other alternative therapy practice and any other stress reduction technique
practice.
ASSUMPTIONS
 Women in menopause may present with vasomotor symptoms
 Soya bean may have a therapeutic effect on menopausal symptoms.
DELIMITATION
 Delimited to only women working in St. John’s National Academy of Health
Sciences – Bangalore
11
PROJECTED OUTCOME
The result of the study will help to identify the effectiveness of soya bean in reducing
menopausal symptoms. This will provide evidence based practice for use of soya bean
as an alternative therapy. This will increase the scope of obstetric nurses in extending
expanded care for women all through the globe.
HYPOTHESIS
 H1- There is a significant change in menopausal symptoms between
experimental and control group.
 H2- There is an association of menopausal symptoms before soya bean
intake with baseline variables.
12
CONCEPTUAL FRAME WORK
The conceptual framework for the present study is based on Imogene king’s theory of
goal attainment. King’s conceptual framework for nursing (1981) consists of three
interacting open systems: (1) individual as personal system (2) Two or more
individuals forming interpersonal system and (3) larger groups, with common interest
forming social system. King’s theory of goal attainment focuses on interpersonal
system and the interaction that take place between individuals, specifically in the
nurse-client association, the dyadic phase.
The theory describes the nature of nurse’s interaction with client to establish goals
mutually and to explore and agree on means to achieve goals. Mutual goal setting is
based on nurse’s assessment of client’s various problems and disturbances in health,
their perception of problems, and their sharing of information with the nurse towards
goal attainment.
Concepts integral to King’s conceptual framework and most applicable to the present
study include perception, reaction, interaction and transaction. Nurses could
utilize communication and interaction to provide women and health professionals with
information regarding the effectiveness of soya bean in reducing menopausal
symptoms22, 23.
Perception: Perception is presented as the major concept of a personal system, the
concept that influences all behaviours or to which all other concepts are related.
Perception was defined as “each person’s representation of reality”. Perceptions are
related to past experience, concept of self, biological inheritance and educational
13
background. King further discusses perception as a process in which data obtained
through the senses and from memory are organized, interpreted and transformed.
In this study, the nurse perceives that women perceive 2 or more menopausal
symptoms per dayand the subjects perceive that Menopausal symptoms are
bothersome and interfere with the quality of life
Reaction: Reaction is the result of communication. Communication is defined as “a
process whereby information is given from one person to another either directly in
face to-face meetings or indirectly through telephone, television or the written word”.
Communication is the information component of the interaction.
In this study, the information component of interaction and the mutual goal setting is
established regarding the reduction of symptoms after consumption of the soya bean
laddu.
Interaction: King defines interaction as a process of perception and communication
between a person and environment and between a person and person represented by
verbal and non-verbal behaviour that is goal oriented.
In this study the interaction takes place between the investigator and the women in
both the groups
 The subjects are informed about the study and a written patient
information sheet is given.
 A general survey is conducted to identify the samples who
would qualify to participate in the study.
 Informed consent is taken.
 Subjects are randomized into experimental and control groups
14
 For the subjects in the experimental and control group, baseline
data and Wiklund menopausal scale is administered in the form
of a structured interview schedule
 Intervention is provided for a period of 15 days i.e. 25 gram of
soya bean laddu is given for the experimental group and 25
gram of rice laddu is given for the control group.
 On the 15th day the Wiklund menopausal symptom scale is
administered.
 The interventions are again continued for another 15 days and
then the Wiklund menopausal symptom scale is administered
on the 30th day
Transaction: Transaction is the valuation component of interaction. It is the
observable behaviour of a human being interacting with environment. Transaction
leads to goal attainment. It is an outcome measure of interaction.
In this study the result of transaction (symptom level) will be compared between the
pre, mid and post- test scores of the experimental and control group to determine the
effectiveness of the intervention. If the goal is attained, there will be a reduction of
menopausal symptoms in the experimental group.
Conclusion:
The researcher has chosen this theory because the researcher feels that nurses could
utilize communication and interaction to provide women and health professionals with
information regarding the effectiveness of soya bean in reducing menopausal
symptoms.
15
The main aim of applying this theory is to attain the goal of improving the quality of
life among women who keep silent about their troublesome symptoms. The
perception, reaction, interaction and transaction can be used effectively and aptly in
attaining the goal of improving the quality of life among menopausal women.
16
17
3. REVIEW OF LITERATURE
A literature review is a body of text that aims to review the critical points of current
knowledge including substantive findings as well as theoretical and methodological
contributions to a particular topic. Its main goal is to situate the current study within
the body of literature and to provide context for the particular reader24.
It is not a chronological catalogue of all of the sources, but an evaluation, integrating
the previous research together, and also explaining how it integrates into the proposed
research program24. The literature is reviewed and organized under the following
headings.

Menopause and its problems

Alternative Therapies for menopausal symptoms

Soy and soy isoflavnones for menopause
MENOPAUSE AND ITS PROBLEMS
Natural menopause occurs with the conclusion of a woman ´s final menstrual period
,it occurs normally between 48–55 years of age and is a complex phenomenon
simultaneously encompassing physiological, psychological and social aspects of a
women‘s life22.Oestrogen deficiency is implicated in an increased risk for vasomotor
symptoms, osteoporosis, cardiovascular disease, urogenital atrophy , cognitive decline
and Alzheimer’s disease10.
In a study conducted in Mumbai among 500 women (40–65 years) of the low socio –
economic strata over 64% were menopausal. Women frequently complained of muscle
and joint pain (37.4%) fatigue (35.6%). the other symptoms reported were hot flushes
18
(19. 4 %) sweating (18.6 %), insomnia (20 .6%) and headache (13.8%). Psychological
changes like mood disturbances are also apparent (27.6%) and urogenital complaints
(7.6%) 12.
To focus on menopause symptomatology of Indian women and how it differed from
women in the United States a study was done on 100 Indian subjects and 117
American subjects. The results showed that the symptom profile of Indian women
appears quite distinct from American women. While Indian women register higher
number of health complaints during menopausal transition phase only, mean numbers
of complaints were consistently higher among American women irrespective of age
categories27.
Midlife is a period of transition for both men and women. Menopause among women,
occurring in middle age, brings in its wake a set of health problems. A quantitative
descriptive study among 100 menopausal women in the age group 45-55; 50 from
urban and 50 from rural pockets respectively. By using the demographic proforma,
modified socioeconomic scale and structured interview schedule, it was concluded
that menopausal health problems were more common among women in rural areas
than in their urban counterparts. 90 % rural women most frequently experienced back
and joint pain while only 78% of the urban women experienced back and joint pain.
The rural women were also less articulate and less aware about managing or
preventing menopausal health problems28.
In the urban areas of South Delhi to assess the knowledge, attitude, problems faced
and remedial measures adopted by menopausal women a descriptive study was done.
A structured interview schedule to assess the baseline and attitude scale to determine
the attitude of menopausal women was used. Out of the total 54% had inadequate
19
knowledge regarding menopause and 51% had positive attitude towards menopause.
89% of the subjects had mood swings and irritability, 78% had constant fatigue, 56%
had hot flushes and 49% had excessive sweating. There was a positive correlation
between attitude of menopausal women towards menopause and the remedial
measures adopted by them. Therefore there is a need to conduct a study to explore the
role of nurses in developing knowledge of women regarding menopause, helping them
to develop positive attitude towards menopause and management of menopausal
symptoms29.
An evaluative study to assess the effectiveness of teaching program on knowledge of
menopausal problems and their management among teachers in selected schools of
Mangalore using one group pre- test and post- test design. The samples comprised of
40 teachers between the age group of 45-59 years selected by convenient sampling
technique. The mean post- test score 25.13% was higher than the mean pre- test
knowledge score. The results proved that the teaching programme helped teachers to
improve their knowledge on menopausal problems and their management30.
Hormone therapy use was significantly associated with reduced risk for falls. In post-
menopausal women bone mineral density did not show any association with postural
balance or risk for falls. A clinical cross sectional study was done in South Eastern
Brazil from March 2009- July 2010 among 225 women who were menopausal and
who belonged to the age group of 45 and above were included in the study. Those
with neurological, musculoskeletal disorders, history of vestibulopathies, uncorrected
visual deficit and drug using patients were not included in the study. The main
purpose was to evaluate the association between postural balance and bone mineral
density in postmenopausal women and its relation to risk for falls. Data was
collected using an interview schedule, physical assessment, bone mineral density
20
assessment and balance evaluation. It was observed that 57. 8% of the participants
reported fall episodes without significant distribution between the groups. 31.
Sleep difficulty is another problem encountered by women. A prospective cohort
study was conducted in England using data on women participating in medical
research council national survey of health and development who have been followed
up from birth in March 1946, relationships between menopausal transition status and
self- reported sleep difficulty were assessed annually between age 48- 54. The analysis
data collected on trouble sleeping; vasomotor, somatic, and psychological symptoms,
waking at night to use the toilet and life stress by using annual postal questionnaires.
The results showed that menopausal transitional status was related to severe self-
reported sleep difficulty. Odds of reporting severe self- reported sleep difficulty were
increased approximately 2 to 3.5 fold for most menopausal transition statuses,
compared to women who remained premenopausal. After adjustment for current
psychological, vasomotor, and somatic symptoms, only women with hysterectomy
remained at an increased risk for moderate sleep difficulty. Women without prior
health problems may experience severe self- reported sleeping difficulty during
menopausal transition and require tailored care from health professionals32.
Depressed mood or variations in mood is a common feature among climacteric
women. A large population based cross sectional study of 639 women aged 45- 54
years to investigate the relations among hot flashes, other menopausal symptoms,
sleep quality and depressive symptoms in midlife women was done in Baltimore. The
data was collected using a questionnaire including the centre for epidemiologic
studies- depression scale, demographics, health behaviours, menstrual history and
menopausal symptoms. The present study found links between depressive symptoms
and several symptoms including hot flashes, sleep disturbances, irritability, muscle
21
stiffness, and incontinence after controlling the covariates. These findings suggest that
a potential mechanism in which bothersome menopausal symptoms may influence
depressed mood during midlife through sleep disturbance33.
A study was done in Finland to prove that vascular function may differ in women with
and without vasomotor hot flushes. 143 recently postmenopausal women with a
broad range of variation in hot flushes were assessed at baseline and after
nitroglycerine and salbutamol challenges. The results showed that after nitroglycrine
challenge, the time of onset of the reflected wave was 9.5% longer and the time to the
first systolic peak was 13.9% longer in women with severe hot flushes as compared
with asymptomatic women. Women with severe vasomotor hot flushes show greater
vascular responsiveness to nitroglycerine than women without hot flushes34.
HRT has become an interesting choice of treatment among women. A study was done
to quantify the relation between use of hormones and risk of breast cancer was done in
postmenopausal women. 725,550 person’s 16 (1976-1992) years of follow up
documented 1935 cases of newly diagnosed invasive breast cancer. The risk of breast
cancer was significantly increased among women on oestrogen plus progesterone or
only on oestrogen, compared to menopausal women who had never used hormones35
In this study articles from indexed journals from 1982-2001 were evaluated, 16 studies
that met inclusion criteria were include in the analysis. The study data synthesised
defined decision making as weighing of benefits and risks. Women’ s consideration
believes and values, as well as interaction with the environment, were primary
influences on the process and that women needed information about process of
menopause and a range of available options for menopause management. Nurses can
22
play a major role in providing information, counselling and developing decision
aids36.
To identify the quality of life among women on hormone therapy, a randomized
placebo, controlled, double-blind study was conducted in the USA among 2763
postmenopausal women( mean age, 67 years) with documented coronary artery
disease to assess the quality of life and depressive symptoms in postmenopausal
women after receiving hormone therapy for 36 months. The study shows that hormone
therapy had mixed effects on quality of life among older women. The effects of
hormone therapy depend on the presence of menopausal symptoms; women without
flushing had greater declines in physical measures, while women with flushing had
improvements in emotional measures of quality of life37
Experience of menopause among women is varied. A qualitative study was done to
assess the menopausal experience among 15 menopausal American women in
Massachusetts. The study identified three major themes or phases like expectations
and realization, sorting things out and a new life phase. Although some women
experienced similar thoughts in particular categories, no two women had the same
experience of menopause. The experience of menopause is unique to each individual
and the meaning or perspective differs among women26.
ALTERNATIVE THERAPIES FOR MENOPAUSAL SYMPTOMS
Complementary and alternative therapies are treatments that are considered
nontraditional. They include dietary and herbal supplements, acupuncture,
chiropractic, and massage therapy, biofeedback, homeopathy, and eating certain foods
that are thought to prevent disease or heal.
23
Alternative treatments are often used alone, while complementary treatments are
alternative treatments that are used in combination with traditional treatments, such as
medication or surgery. Many women going through menopause try to get relief from
their symptoms by including phytoestrogens, or natural estrogens, in their diet. There
are also other nutritional supplements that are touted to help relieve menopausal
symptoms, such as black cohosh and flaxseed38. Natural products or mind and body
practices are sometimes used in an effort to relieve menopausal symptoms such as hot
flashes and night sweats. Since the 2005 NIH panel’s findings, scientists are
continuing to build an evidence base on complementary therapies for menopausal
symptoms. Although questions remain, research is progressing. For example,
NCCAM is sponsoring studies on mind and body approaches that have shown promise
for reducing menopausal symptoms, and on products that are both well characterized
(i.e., their ingredients have been carefully studied) and well standardized39.
Yoga is an ancient science and art. It has been practised over ages and has no negative
aspects. Yoga has some remedies for menopausal symptoms. A study in New Delhi
showed that post-menopausal women who practiced yoga had a bone mineral density
higher than women only on calcium supplements with a confidence interval of 99%
and p value of 0.0023 and higher than women who took Hormone replacement
therapy with a confidence interval of 99 % and p value of 0.0009. Aches and pains
were only 10% in women who practiced yoga, 80 % in women who took calcium
supplements and 64 % in women who took hormone replacement therapy 17.
Herbal interventions are a treatment of choice opted by women. A one year
randomized double blind, placebo controlled study was conducted among 351 women
aged 45-55 years with two or more symptoms per day in Washington state to test the
efficacy of three herbal regimens and hormone therapy for relief of vasomotor
24
symptoms compared with placebo. The results showed that the vasomotor symptoms
per day, symptom intensity Wiklund vasomotor symptom subscale score did not differ
between the herbal interventions and placebo at three, six and twelve months or for the
average overall follow up time points. At twelve months symptom intensity was
significantly worse with multibotanical plus soy intervention than with placebo19.
A prospective randomised control study was conducted in New Delhi among women
who were attending gynaecology OPD in a medical college hospital. 34 women were
studied, out of which 20 women were put on menopace supplement and the remaining
14 women were put on a placebo daily. 25 women completed the trial and the effect
on menopausal symptoms and lipid profile after 3 months of treatment was studied.
The improvement was highly significant with menopace than with the placebo
(p<0.05). There was improvement in the lipid profile also with menopace than with
the placebo although the difference was not statistically significant. Combination of
multi- vitamins and minerals (menopace) appears to be effective and safe for
treatment of menopausal symptoms40.
Tai chi is a mind body exercise that shows potential as an effective and safe
intervention for preventing fall related fractures in elderly. A pragmatic randomized
trial was conducted on 86 postmenopausal osteopenic women, aged 45- 70 were
recruited from community clinics in Boston to assess the impact of Tai chi exercise on
multiple fracture- related risk factors in postmenopausal osteopenic women. Women
were assigned to either nine months of training plus usual care vs. usual care alone.
Primary outcomes were changes between baseline and nine months of bone mineral
density of the proximal femur and lumbar spine and serum markers of bone resorption
and formation. Secondary outcomes included quality of life. In a sub- sample of 16,
quiet standing fall predictive sway parameters and clinical balance tests were also
25
assessed. For bone mineral density, no intent to treat analysis was statistically
significant; however per protocol analyses of femoral neck bone mineral density
changes were significantly different between tai chi and usual care(+0.04 vs. -0.98%;
p= 0.05). Changes in sway parameters were significantly improved by tai chi. Tai chi
training offered through community based programs is safe, feasible, and promising
intervention for reducing multiple fracture risks in postmenopausal women41.
Insomnia is highly prevalent and affects between 28%- 63% of postmenopausal
women. The search for complementary therapies is increasing, massage therapy being
among these. The objective of this study was to evaluate the effectiveness of
therapeutic massage on insomnia, depression and anxiety through subjective and
objective parameters in postmenopausal patients with insomnia. The study was
conducted among seven postmenopausal women with insomnia in Brazil. After
assessing the subjects using a screening interview by a complete medical history,
anamnesis and Kupperman index as well as complete gynaecological and
haematological examinations were submitted to 16 one hour sessions of massage
twice weekly and were evaluated on psychological and physiological parameters.
Polysomnography revealed a decrease in rapid eye movement latency and increased
stages three and four. The results showed that there was a significant improvement in
the symptoms of anxiety and depression and that the participants fell asleep more
rapidly. The study showed that there was a decrease in insomnia, anxiety and
depressive symptoms and the treatment also suppressed other menopausal
symptoms42.
Hot flashes are the most important complaint of postmenopausal women. Almost
2/3rd of menopausal women have hot flashes and nearly 20% find them to be
intolerable. The recent findings from women’s health initiative have important
26
implications for mind- body intervention for hot flashes. Hypnosis is a mind- body
intervention that has shown to reduce self- reported hot flashes by up to 68% among
breast cancer survivors. The objective of this RCT was to assess the effectiveness of
hypnosis for hot flashes among postmenopausal women in the USA. A sample of
180 post-menopausal women were randomly assigned to either a five session hypnosis
or a five session structured attention control. Outcomes such as hot flashes, anxiety,
depression, sexual functioning and sleep quality and cortisol were assessed by reliable
and validated scales. The results of this study are not yet published. It is one of the
first studies to examine both the perceived impact and physiological impact of a mind
body intervention; the first study to examine the effect of hypnosis for hot flashes on
cortisol43.
A randomized trial of 110 late perimenopausal women experiencing average of 5 and
greater than 5 moderate or severe hot flashes in Massachusetts was conducted to
assess mindfulness training for coping with hot flashes. A wait list was used, with
three month post intervention follow up. Main outcome was degree of bother from hot
flashes and night sweats in previous 24 hours. Secondary measures were hot flush
intensity, quality of life, insomnia, anxiety, and perceived stress. Women randomized
to the intervention arm were able to select one of three concurrent mindfulness
training stress reduction classes (evening and day time) classes were conducted by
centres who were blinded to the study outcomes. At completion of intervention, bother
in the experimental arm decreased on average by 14.77% versus 6.79% for the control
group. At 20 weeks, total reduction in both for the interventional arm reduced by
21.62% and 10.50% for the wait list. The interventional arm also had clinically
significant improvements in quality of life, subjective sleep quality, anxiety and
perceived stress. The improvements were maintained three months post intervention44.
27
A 24 week, placebo- controlled, randomized intervention trial to investigate the effects
of green tea polyphenols and tai chi was conducted in China among 171 post-
menopausal women with osteopenia. The subjects were randomly assigned to four
treatment arms for 24 weeks. One group received the placebo, the second tai chi, the
third placebo plus tai chi and the fourth green tea polyphenol training plus tai chi
training. Quality of life was assessed using SF- 36 questionnaire at baseline, 12 and 24
weeks. 150 subjects completed the study. Green tea polyphenols at a dose of 500 mg/
day and/or tai chi exercise at 3 hours/week for 24 weeks appear to be safe in post-
menopausal osteopenic women. Tai chi exercise for 24 weeks significantly improved
quality of life in terms of role- emotional and mental health in these subjects45.
Maca is an Andean plant of the Brassica family (mustard). Preparations from Maca
root have been reported to improve sexual function. A systematic review was done in
South Korea to assess the clinical evidence for or against the effectiveness of the
Maca plant. The researchers searched 17 databases from their inception to April 2010
and included RCT’s of any type of Maca compared to a placebo for treatment of
healthy patients or humans with sexual dysfunction. Four RCT’ s met inclusion
criteria, 2 RCT’ s suggested a significant positive effect of Maca on sexual
dysfunction or sexual desire in healthy menopausal women or healthy adult men,
respectively, while the other RCT’s failed to show any effects. The further RCT
assessed the effects of Maca in patients with erectile dysfunction using the
international index of erectile dysfunction-5 and showed significant effects. The
results of the systematic review provide limited evidence for the effectiveness of maca
in improving sexual function46.
A randomized, four arm, double blinded clinical trial was conducted in Chicago of
standardised black cohosh, red clover, placebo and 0.625 mg of conjugated equine
28
estrogens plus 2.5 mg medroxyprogesterone acetate. Primary outcome measures were
reduction in vasomotor symptoms by black cohosh and red clover compared with
placebo; secondary outcomes included safety evaluation, reduction of somatic
symptoms, relief of symptoms and overall improvement in quality of life. Reduction
in number of vasomotor symptoms were as follows: black cohosh (34%), placebo
(63%), CEE/MPA (94%), with only CEE/MPA alone differing from the placebo. In
general there were no improvements in menopausal symptoms46.
Cognitive behavioural therapy and physical exercise were potentially useful measures
among women with breast cancer undergoing treatment induced premature
menopause. A randomized, controlled, multicentre trial to evaluate the effectiveness
of cognitive behavioural therapy/ relaxation, of physical exercise and of these two
programs combined in reducing menopausal symptoms, improving sexual functioning,
reducing emotional distress and in improving the health related quality of life of
younger breast cancer patients who experience treatment induced menopause was
conducted in Netherlands. 325 breast cancer patients aged less than 50 were recruited
from Amsterdam region and randomly allocated to one of the tree treatment groups or
control group. Self- administered questionnaires were completed by patients at
baseline, 12 weeks and six months post- study entry. The results showed that it was
useful48.
Acupuncture is another treatment of choice. A multicentre randomized controlled
trial with 2 parallel arms will be conducted in Korea to assess the effectiveness of
acupuncture on hot flashes in perimenopausal and postmenopausal women.180
participants will be randomized to the acupuncture treatment plus usual care or usual
care alone group and divided into 4 centres. Each centre will recruit 45 participants;
30 to acupuncture plus usual care and 15 to usual care alone. The treatment group will
29
receive acupuncture 3 times a week, for a total of 12 sessions over 4 weeks. The
control group will receive usual care during the same period. Post- treatment follow
up will be performed after one month after completing 12 sessions. This trial would
provide evidence for effectiveness of acupuncture as a treatment for hot flashes49.
Aromatherapy massage is an effective intervention to reduce fat in postmenopausal
women. A non- equivalent control group pre-post testquassi- experimental design of
random assignment was conducted in Korea. All subjects received one hour of whole
body massage as treatment by the same researcher every week for 6 weeks.
Participants also massaged their own abdomen two times daily for 5 days each week
for six weeks. The two groups used different kinds of oil. The experimental group
used 3% grapefruit oil, cypress and 3 other kinds of oil. The control group used grape
seed oil. The data was collected before and after the treatment using Siemens
SomaticSensation 4, a tape measure and MBSRQ. Abdominal subcutaneous fat and
waist circumference in the experimental group significantly decreased after
aromatherapy massage compared to the control group. Body image in experimental
group was significantly better after aromatherapy massage than in the control group.
The results suggest that aromatherapy massage could be utilized as an effective
intervention to reduce abdominal subcutaneous fat, waist circumference, and to
improve body- image in postmenopausal women50.
Relora was effective in reducing temporary and transitory anxiety. A randomized,
parallel, placebo, controlled clinical study was conducted in Miami with healthy,
overweight premenopausal female adults, between the ages 20 and 50 years, who
typically eat more in response to stressful situations and scores above the national
mean for women on self- reporting anxiety. The intervention was Relora 250mg
capsules or placebo 3 times daily. Anxiety was measured by the Spielberger STATE-
30
TRAIT questionnaires, salivary amylase and cortisol levels. Likert scales for sleep
quality and latency, appetite, and clinical markers of safety. The intent to treat
population was 40 subjects with 26 completing the study. The results of the study
showed that Relora was effective 51.
St. John’sWort and black cohosh are effective herbal alternatives to reduce climacteric
symptoms. This randomized, double- blinded placebo –controlled, multi-centre study
was conducted in Korea among 89 perimenopausal or postmenopausal women
experiencing climacteric symptoms. The subjects were treated with St. John’ s wort
and black cohosh extract or matched placebo for 12 weeks. Climacteric conditions
were evaluated by Kupperman index initially and at 4 and 12 weeks following
treatment. Vaginal maturation index, serum estradiol, FSH, LH, total cholesterol and
triglycerides were measured before and after treatment. 77 completed the trial. The
results showed that the mean Kuppermanindex scores and hot flushes after 4and 12
weeks were significantly lower in the experimental group. HDL levels decreased in
control group from 60.20±16.37 to 56.63±12.67 and increased in the gynoplus group
from 58±11.64 to 59.74±10.54. black cohosh and St. John’ s Wort combination was
found effective in alleviating climacteric symptoms and might provide benefits to lipid
metabolism52.
A multicentre pragmatic randomized controlled trial with two parallel arms would be
conducted in Norway. Participants are postmenopausal women who documented
seven or more than seven flushes / 24 hours who are not on HRT or other medications
that may influence flushes. According to power calculations 200 women are needed to
detect 50% reduction in flushes and altogether 286 will be recruited with a 30 % drop
rate. The treatment group receives ten sessions of traditional Chinese medicine
acupuncture care and self- care and control group only self- care. The intervention
31
period lasts from 12 weeks with follow up at 6 months and 12 months. Primary end
point is change in daily hot flush frequency in the two groups from baseline to 12
weeks; secondary end point is quality of life assessed by women’s health
questionnaire. Finally a measure of biological variables, to examine potential
mechanisms for the effect of acupuncture is done53.
The MEDLINE database was searched for clinical trials of non- estrogenic plant
extracts for menopausal symptoms. To be included studies had to include peri or
postmenopausal women as subjects. All clinical trials were included for this review.
The results showed that black cohosh appears to be one of the most effective
botanicals for relief of vasomotor symptoms, while St. John’ s Wort can improve
mood disorders related to the menopausal transition. Many other botanicals have
limited evidence to demonstrate safety and efficacy for relief of symptoms related to
menopause54.
Phytoestrogen extracts, including soy foods and red clover appear to have at best only
minimal effects on menopausal symptoms but have positive health effects on plasma
lipid concentrations and may reduce heart disease. A systematic review was done to
review the botanicals and dietary supplements commonly used in menopause as well
as the available data on efficacy and safety. MEDLINE data bases from 1996-
December 2004 was searched. Abstracts from relevant meetings as well as reference
books and websites on herbal supplements were also searched. RCT’s were used if
available. The evidence to date suggests that black cohosh is safe and effective for
reducing menopausal symptoms, primarily hot flashes and possibly mood disorders St.
John’ s wort has been shown to improve mild to moderate depression in the general
population and appears to show efficacy for mood disorders related to menopausal
32
transition. Other commonly used botanicals have limited evidence to demonstrate
safety and efficacy for relief of symptoms related to menopause55.
Herb users had experienced more menopausal symptoms than non-users and had more
side effects from hormone therapy. A descriptive survey of herbal use utilizing
responses from a questionnaire was conducted in a health food grocery in South-
eastern USA. A convenience sample of 40 women, ages 40-65 were included.
Menopause symptoms perceived efficacy of hormone or herbal therapy, herbs used,
sources of information about herbs and discussion with health care providers about
herbal use were the main outcome measures. The results showed that 2/3rd of the
women had used herbs for peri-menopausal symptoms. Herb users relied on
information about herbs from alternative health care providers, whereas non- users
relied on popular media and peers. Overall, less than half were asked by their health
care providers about herbal use. Furthermore, nearly half expressed dissatisfaction
with the information given by providers about herbs. Although black cohosh was the
most frequently used herb, ginseng and gingko were perceived to be the most
effective18.
SOY AND SOY ISOFLAVONES FOR MENOPAUSE
Soy products are considered to have phytoestrogenic properties. Soy products are
particularly rich in isoflavones, primarily genistein and daidzein. Soy acts as estrogen,
anti–estrogen, antioxidant and immune enhancer. They are structurally similar to
oestrogen hormones women produce, but they are different enough not to be fully
fledged steroidal hormones. They also act as anti – oestrogens and that is why they
reduce the risk of cancer. Oestrogen signals a cell to proliferate that is why it is
carcinogenic. Genistein has only 1/ 1000 the hormonal activity of oestrogen, attaches
33
to the breast cells oestrogen receptors and thereby blocks the most potent female
hormones from attaching , so in oestrogen deficiency states, isoflavones can attach to
open oestrogen receptor sites on cells and produce a weak oestrogen effect.
Isoflavones can reduce cancer risk by inhibiting the activity of tyrosine kinase, an
enzyme that promotes cancer cell growth, and therefore they are cancer enzyme
inhibitor. They are antioxidants by preventing free radical damage to DNA, the
complex molecule that contains genes. They reduce the risk of cancer by activating
immune cells, thereby an immune enhancer56.
A study was conducted to determine the effectiveness of soy on menopausal problems
among women. A pre- test, post- test control group experimental study was done in
two rural areas in Tamil Nadu. The target population were women in the age group
between 40- 65 years of age. First week pre- test was administered which consisted of
a tool with baseline in part one and menopausal symptoms in part two. The
experimental group was given 25 gram of roasted soya powder mixed with jaggery
daily for a period of 30 days and control group was given no intervention. At the end
of the 6th week post- test assessment was done again. The study results showed that
the intervention was effective in reducing menopausal problems as the mean selected
menopausal problems level after the administration of soya was lower than the mean
selected menopausal problems level before the administration of soya among
menopausal women57.
Soy products are currently the most popular alternative to HRT. A prospective study
was undertaken from November 2002- 2004. The women who were eligible were
asked to respond to a questionnaire with baseline characteristics and Kupperman’ s
Index. They were then administered 75 mg of soya isoflavones per day. A total of 31
subjects completed the 12 month study. Women receiving soy experienced a 28%
34
(p<.001) reduction in hot flushes, while the placebo showed an 18% reduction
showing thte placebo effect. The Kupperman’ s Index became statistically significant
from the third month onwards and remained the same till the end of the study58.
A pilot study conducted in Mumbai to see if phytoestrogens could take a place as
alternative to hormone replacement therapy. Here 70 (51.5, average age)
perimenopausal women were taken. The women were subject to take Evanova – 30
milligram capsules. The subjects were examined before the treatment and later every
two months for six months. Nine out of eleven patients (81.8%) with vasomotor
problems were relieved significantly. Though this is a short term study 45 patients
wanted to continue the treatment and have been followed up for 12 months and 25 of
them have continued the treatment for 24 months. Of the 25 who stopped the
treatment at six months, 15 had no complaints and ten were lost to follow up9.
Recent analysis has challenged the effectiveness of soy foods as part of a cardio
vascular reduction diet. The objective of the study was to show whether equol status
determines the effectiveness of soy foods to lower cholesterol and to raise HDL
cholesterol. 85 hypercholesterolemic men and postmenopausal women participated
in 1 of 3 studies that represented a range of soy interventions and that followed the
same general protocol at a Canadian university hospital centre. Soy foods were
provided for one month at doses of 30-52 gram per day for the 3 studies as follows: 1)
soy foods with either high normal (73mg/day) or low isoflavnones(10 mg/ day) 2) soy
foods with or without a prebiotic to enhance colonic fermentation (10g polyfructans/
day) 3) soy foods with a low carbohydrate diet (26%). Studies one and two were
randomized controlled trials and study three was a parallel study. The study showed
that soy foods reduced serum LDL cholesterol equally in both equol producers and
35
non -producers. However, in equol producers, 35 % of the study population, soy
consumption had the added cardiovascular benefit of maintaining higher HDL
cholesterol concentrations than those seen in equol non producers59.
To determine the effect of the miracle bean. A randomized, controlled, crossover trial
was conducted in Massachusetts among 60 healthy postmenopausal women to
examine the effect of soya nuts on hot flashes and menopausal symptoms. The
women were randomized in a cross over design to therapeutic lifestyle changes diet
alone and a TLC diet of similar energy, fat, and protein content in which one half cup
soya nuts divided into 3 or 4 portions spaced throughout the day containing 25 gram
soy protein and 101 mg aglyconeisoflavones replaced 25 gram non soy protein.
During each 8 week period, subjects recorded the number of hot flushes and amount
of exercise daily. At the end of 8- week diet period, subjects filled out the menopausal
symptom quality of life questionnaire. The results showed that the TLC diet plus soy
nuts was associated with a 45 % decrease in hot flushes, it was also associated with
significant improvements on the menopausal symptom quality of life questionnaire;
19% decrease in vasomotor score, 12.9% reduction in psych-social score, 9.7%
decrease in physical score and a trend towards improvement in the sexual score, with a
17.7% reduction in symptoms60.
Soya has always proved healthy. A multi-centre, randomized, double- blinded,
placebo controlled 24 month trial was conducted in California to assess the effect of
daily supplementation with 80 or 120 mg aglycone equivalent soy hypocotyl
isoflavones plus calcium and vitamin D on the health of 403 menopausal women. At
the baseline and after 1 and 2 year, clinical biochemistry values were measured and a
well-woman examination was conducted which included a mammogram and a
papnicolaou test. A cohort also underwent a transvaginal ultrasound to assess the
36
endometrial thickness and fibroids. After 2 years the clinical chemistry values
remained the same, the only variable that changed was blood urea nitrogen which
increased significantly after 2 years. The results showed that daily supplementation of
80- 120 mg soy hypocotyl isoflavones for 2 years has minimal risk in healthy
menopausal women61.
The findings support the hypothesis that a diet characterized by vegetables, fruits and
soy has an early protective effect on breast carcinogenesis. A cohort study was
conducted in Singapore among 62,257 men and women recruited between April 1993
and December 1998 aged between 45- 74 years. At the baseline, A 165 item food
frequency questionnaire was administered. Two distinct dietary patterns were labelled
vegetable-fruit-soy; 23 vegetables, 5 soy foods and 5 fruits, and meat-dim-sum diet
including 7 meat items,12 dim sum diets; 4 starch items and 3 combined meat starch
item and 1 egg item. As of December 2005, with intake of vegetable-soy- fruit diet a
dose dependent trend for decreasing breast cancer among post-menopausal women
was noticed. A stronger association was noticed at 5 years and greater62.
A randomized, double- blinded trial was conducted in Australia among 58 post-
menopausal women with at least 14 hot flushes per week, with an aim to determine
that their daily diet supplemented with soy flour could reduce hot flushes compared
with wheat flour over 12 weeks. Hot flushes significantly reduced by 40% in the soy
group and 25% in the wheat group with a significant rapid response in soy flour group
in 6 weeks that continued. Menopausal symptom score decreased in both groups.
Urinary daidzein excretion confirmed compliance. Vaginal cell maturation, plasma
lipids and urinary calcium remained unchanged. Serum FSH decreased and urinary
hydroxyproline increased in the wheat flour group63.
37
A three way cross-over study was conducted in Indiana to identify the effective dose
of soy protein isolate enriched with isoflavones for suppressing bone resorption in
postmenopausal women using a novel, rapid assessment of ant- bone resorbing

41
treatments. 13 post-menopausal women were predosed with Ca iv. After a 200 day
baseline period, subjects were given 43 gram soy protein per day. The soy protein
isolate powder was incorporated into baked products and beverages. Each 50 day
intervention phase was preceded by a 50 day treatment phase for comparison. Serum
isoflavone levels and biochemical markers were measured at the end of each phase. 24
hour urine samples were collected approximately every ten days during each phase for
41
Ca/ Ca ratios. Soy protein with isoflavone doses up to 135.5 mg/ day did not
suppress bone resorption in post-menopausal women64.
To determine if a supplement of soy protein improves body composition, body fat
distribution, and glucose and insulin resistance in non- diabetic post-menopausal
women compared to an isocaloric casein placebo, a randomized, double- blinded,
placebo controlled threemonth trial was conducted in Alabama on 15 postmenopausal
women The main outcome measures were total fat, total abdominal fat, visceral fat,
subcutaneous abdominal fat and insulin secretion examined through CT scans at
L4/L5, dual energy absorptiometry, and hyperglycemic clamps. The results showed
that a daily supplement of soy protein prevents the increase in subcutaneous and total
abdominal fat observed with an isocaloric casein placebo in postmenopausal women65.
To empirically state the effect of soya on the bone, a double blinded parallel study was
conducted in Oklahoma to examine if one year consumption of soy- containing foods
(25 gram of protein and 60 mg isoflavones) exerts beneficial effects on bone in
38
postmenopausal women. 87 eligible postmenopausal women were randomly assigned
to consume soy foods or control foods daily for one year. Bone mineral density and
bone mineral content of the whole body was assessed at baseline and after one year.
Blood and urine markers of bone metabolism were also assessed. 62 subjects
completed the one year- long study. Whole body and lumbar bone mineral density and
bone mineral content were significantly decreased in both the soy and control groups.
The findings suggested that one year supplementation of 25 gram soy protein per se
positively modulated markers of bone formation; this amount of protein was unable to
prevent lumbar and whole body bone loss in postmenopausal women66.
To prove the effect of soya yet another randomized double blinded study in Brazil was
conducted among 80 women between 45- 55 years, to assess the effectiveness of soy
isoflavone. The subjects were subject to the therapy and re – examined after 4 months.
The statistical analysis showed a decrease in menopausal symptoms after 4 months (
p< .01 ) between baseline and isoflavnone group and (p< .01 ) between placebo and
isoflavnone and group. This study also showed that there was a decrease in low
density lipoproteins levels, which suggest a positive effect on the cardiovascular
system67.
The objective of the study was to examine if one year consumption of soy containing
foods exerts beneficial effects on bone in postmenopausal women. A double blinded
parallel study was done among 87 eligible postmenopausal women younger than 65
years of age. Herein 25 grams protein products in the form of a snack bar, drink mix
or cereal and were consumed daily for a period of one year. Out of 62 subjects who
completed the one year- long study, whole body and lumbar bone mineral density and
bone mineral content were significantly decreased in both the soy and control groups.
The findings suggested that although the one year supplementation positively
39
modulated markers of bone formation, this amount of protein was unable to prevent
lumbar and whole body bone loss in postmenopausal women68.
A randomized double blind parallel multicentre placebo controlled study, in Italy of
104 menopausal women between the age group 48-61. They were divided into two
groups and 60 gram soya was given to one and 60 gram casein was given to the other
and they were evaluated after 4, 8 and 12 weeks. At the baseline, median number of
hot flushes was 11.4 for group taking soy and 10.9 for placebo group. A 26 %
reduction by the third week, by the fourth week a 33 % reduction and at twelfth week
a 45% reduction (p<0.01). The placebo at the end of the 12th week had 30 %
reduction. Thereby the study proved that soya protein in the diet substantially reduced
the frequency of hot flushes69
40
4. METHODOLOGY
The research methodology includes the research approach, research design, setting,
population, sample and sampling techniques, development and description of the tool,
data collection procedure, pilot study and plan for data analysis. This chapter gives a
brief description of the methodology adopted for the study to assess the effectiveness
of soya bean on menopausal symptoms among women working in St. John’s National
Academy of Health Sciences– Bangalore.
RESEARCH APPROACH
It is a quantitative study in which the researcher performs the intervention on two
groups, the experimental group and the control group.
RESEARCH DESIGN
The research design is an experimental research design with an experimental group
and control group.
41
MENOPAUSAL WOMEN WORKING IN ST.JOHN’ S
TARGET POPULATION NATIONAL ACADEMY OF HEALTH SCIENCES-
BANGALORE
40 MENOPAUSAL WOMEN WORKING IN ST.

SAMPLE AND SAMPLING JOHN’ S NATIONAL ACDEMY OF HEALTH
TECHNIQUE SCIENCES BANGALORE
SIMPLE RANDOM SAMPLING TECHNIQUE
STANDARDIZED WIKLUND MENOPAUSAL

TOOL SYMPTOM SCALE BEFORE, DURING AND
AFTER THE INTERVENTION
DATA ANALYSIS DESCRIPTIVE AND INFERENTIAL STATISTICS
SOYA BEAN WILL REDUCE THE

MENOPAUSAL SYMPTOMS
OUTCOME SIGNIFICANTLY. THIS WILL PROVIDE
EVIDENCE BASED PRACTICE FOR USE
OF SOYA BEAN AS AN ALTERNATIVE
THERAPY.
Figure2 Schematic representation of the study design
42
POTENTIAL CANDIDATES (292)
MEDICAL COLLEGE (110), MRD (22), BIOCHEMISTRY (20), MICROBIOLOGY

(20) NOT WILLING
SURVEYED (120)
PARTICIPANTS (50); ATTRITION (10)
20
40 PARTICIPANTS
EXPERIMENTAL 20 CONTROL 20
PRE-INTERVENTION ADMINISTRATION OF
SCALE
SOYABEAN LADDU 25 GRAMS FOR 15

RICE LADDU 25 GRAMS FOR 15 DAYS
DAYS
MID-INTERVENTION ADMINISTRATION OF
SCALE ON THE FIFTEENTH DAY
SOYABEAN LADDU 25 GRAM RICE LADDU 25 GRAMS FOR THE

FOR NEXT 15 DAYS NEXT 15 DAYS
POST-INTERVENTION ADMINISTRATION OF SCALE ON THE

THIRTIETH DAY
Figure 3: Schematic representation of the research design
43
VARIABLES
The three types of variables in the present study are the dependent variables,
independent variables and extraneous variables
Dependent variables: In the present study the menopausal symptoms on the Wiklund
menopausal symptom scale are the dependent variables.
Independent variables: The soya bean laddu is the independent variable in the
present study.
Extraneous variables: In this study, the extraneous variables are age, education,
occupation, body mass index (BMI), marital status, age at menopause and type of
menopause (surgical / natural), support system, alternative system of medicine
practice and stress reduction technique practice.
SETTING
The study was conducted among all working women in St. John’s National Academy
of Health Sciences – Bangalore. St. John’s National Academy of Health Sciences is a
tertiary hospital and teaching institution for medical and paramedical students. The
hospital is 1200 bedded.
POPULATION
The population of this study comprises of all working menopausal women in St.
John’s National Academy of Health Sciences, presenting with two or more symptoms
per day in the Wiklund Menopausal symptom scale, persisting for the last one month.
The total number of working women in St. John’s National Academy of Health
Sciences who are likely to be menopausal approximately would amount to 292.
44
SAMPLING PROCEDURE
In this study all the prospective subjects meeting the inclusion criteria were surveyed
and then they were randomly allocated to the experimental and control group by
simple random sampling using SPSS random table allocation.
SAMPLE SIZE
In this study, sample comprised of 40 women, with menopausal symptoms, 20 in the
control group and 20 in the experimental group. The sample size was decided based
on the review of literature and statistical calculations58.
2
N= *2
D2
INCLUSION CRITERIA
All working women who have attained menopause naturally and surgically(after 6
weeks have elapsed) within a duration of one to ten years and presenting with two or
more symptoms per day in the Wiklund menopausal symptom scale persisting for the
last one month.
EXCLUSION CRITERIA
1) Women who already consume soya bean regularly.
2) Women who are on hormonal replacement therapy.
3) Women with thyroid disorders and renal disorders.
4) Women with Diabetes mellitus.
5) Women with known food allergies.
45
INSTRUMENTS
The instrument used was based on the objectives. The instrument contains
1) Survey format to assess the prevalence and identify the potential participants
2) A structured interview schedule for the collection of baseline variables.
3) Wiklund menopausal symptom scale
It has 13 menopausal symptoms rated on a scale of 0-10; where (0 – none and
10 – maximum). The scale is a standardized scale and the scale was used after
due permission was received from the authors who used it previously. The
symptoms on the scale are
 Sweats  Palpitations
 Hot flushes  Dizziness
 Sleep disturbances  Breast tenderness
 Fatigue
 Vaginal dryness
 Depression
 Head ache
 Irritability
 Muscle/joint pain
 Nervousness
PILOT STUDY DETAILS
The study was conducted between 24/5/12- 7/6/12 in St. John’ s National Academy of
Health sciences – Bangalore among 6 subjects who met the inclusion criteria. Written
informed consent was taken from the subjects explaining the details of the study. An
initial survey was done, and then the subjects were randomly allocated into control
46
and experimental group using simple random sampling (lottery method). Participants
were asked to rate their symptoms on the Wiklund menopausal symptom scale before
the intervention. The intervention was then administered for seven days. On the
seventh day the Wiklund menopausal symptom scale was again administered. The
intervention was then continued again for another eight days and the Wiklund
menopausal symptom scale was again administered on the fifteenth day to monitor the
difference in the symptoms after the intervention.
The data was analyzed using descriptive and inferential statistics. There was an
improvement in hot flushes, sweats, fatigue, muscle and joint pain in the experimental
group and in the control group there was an improvement in fatigue and muscle/ joint
pain. The subjects in the experimental group verbalized weight loss by the end of the
study and a feeling of lightness. Therefore it was decided that weight should be
checked along with the mid and post- test administration of the Wiklund menopausal
symptom scale. There was an improvement in menopausal symptoms in 15 days’
time; therefore the duration of the post assessment was reduced from 60 days to 30
days for the final study, eventually the mid assessment for the final study was done on
the fifteenth day. The pilot study findings showed that the study was feasible. Expert
opinion was valued and incorporated for the main study.
DATA COLLECTION METHOD
1. Ethical clearance was received from the institutional ethical review board.
Formal written permission was received from the associate director hospital
and medical college. The final study data collection started from 23/5/12-
4/8/12 in St. John’ s National Academy of health sciences- Bangalore.
47
2. The sampling unit was collected from the personnel department. The sample
collected for the pilot study was removed from the list of staff who were
potentially menopausal.
3. Then a survey was conducted on women to identify the prevalence, and to see
if the clients fell within the inclusion and exclusion criteria. Out of 292
potential menopausal women the doctors and workers of the medical college
(110), staff of the medical records department(22), biochemistry(20) and
microbiology(20) lab were not willing to participate in the study and they
totally amounted to 172. Out of the remaining 120 the researcher surveyed, 50
met the inclusion and exclusion criteria. Out of the 50 participants’ attrition of
10 participants happened as they did not continue the therapy because of
reasons like sudden emergency leave and offs.
4. A written informed consent was taken from all subjects after explaining the
details of the study. The samples thus obtained were then categorized into the
experimental and control group by simple random sampling using SPSS
package.
5. The tool was administered in the form of a structured interview before the
intervention.
6. The experimental group was given 25 gram soya bean laddu and the control
group was 25gram riceladdu for a period of 30 days.
7. On the fifteenth day the Wiklund menopausal symptom scale was administered
and weight was checked for the subjects
8. On the thirtieth day the Wiklund symptom scale was administered again and
the weight was checked again.
48
DATA ANALYSIS PLAN
Steps taken to analyse data
 Organised the data in a master sheet
 Calculated the frequency and percentage on distribution of subjects according
to baseline variables.The significance of the corresponding variables was
calculated by chi square and Fischer exact test.
 Calculated the mean, standard deviation of pre, during and post test scores of
 Independent t- test and Repeated measures ANOVA value of pre, during and
post test score to determine the effectiveness of the intervention
 ANOVA and t- test to find the association between menopausal symptom
score and selected baseline variables.
49
5. RESULTS
This chapter deals with the analysis and interpretation of the data gathered to assess
the effectiveness of soya bean on menopausal symptoms among women working in St.
John’s National Academy of Health Sciences– Bangalore. The results of the study are
computed using descriptive and inferential statistics based on the following objectives
of the study.
OBJECTIVES
2. To determine the association between menopausal symptoms before
intervention with baseline variables
ORGANIZATION AND PRESENTATION OF THE DATA
The obtained data were entered into the master sheet for tabulation and statistical
processing. The analysis of the data was organized and presented under the following
sections.
SECTION 1: Findings related to baseline variables
SECTION 2: Findings related to the assessment of menopausal symptoms before,
during and after the intervention in the experimental and control group
SECTION 3: Findings related to association between menopausal symptoms and
selected baseline variables.
50
SECTION 1: FINDINGS RELATED TO BASELINE VARIABLES
TABLE 1a: Distribution of participants according to duration of menopause,

education, occupation and marital status of women with menopausal symptoms
n= 40
s.no Baseline Experimental group Control group Test of P -value

variables significance
Frequency Percentage Frequency Percentage ᵡ2

1 Duration of
menopause:
1-3 11 55.00 10 50.00
4-6 5 25.00 3 15.00 1.366 0.505
7-10 4 20.00 7 35.00 NS
2 Education
Illiterate 11 55 12 60 0.801 0.819
*
School 5 25 6 30 F NS
>school 4 20 2 10
3 Occupation
Clerical 2 10.00 3 15.00 0.232 0.890
Unskilled 16 80.00 15 75.00 NS
Professional 2 10.00 2 10.00
4 Marital status
Married 15 75.00 16 80.00 0.143 1.000
*
Others 5 25.00 4 20.00 F NS
*
NS not significant F Fischer exact test
Table 1a depicts that, 55%in the experimental group and 50% in control group have a
duration of 1-3 years of menopause. It is identified that 55% women in experimental
and 60% in control group are illiterate. Most of the women, 80% in the experimental
and 75% in control group are unskilled. Majority of the subjects 75% are married in
the experimental group and 80% are married in the control group. There is no
significant difference between selected baseline variables in the control and
experimental group.
51
TABLE 1b: Distribution of participants according to support system, alternative
system of medicine practice, type of menopause and BMI of women with
menopausal symptoms.
n=40
s.no Baseline Experimental group Control group Test of p- value

variables significance
Frequency Percentage Frequency Percentage ᵡ2
1 Support
system
Yes 7 35.00 10 50.00 0.337
No 13 65.00 10 50.00 0.921 NS
2 Alternative
system
practice
Yes
No 20 100.00 20 100.00
3 Type of
menopause
Natural 17 85.00 16 80.00 0.001 0.001**
Surgical 3 15.00 4 20.00 *F
4 BMI
<=18.5 3 15.00 2 10.00 1.000 0.607
18.5-23.5 6 30.00 9 45.00 *F NS
>=23.5 11 55.00 9 45.00
*
**highly significant NS not significant F Fischer exact test
Chi-square test is used to test the significance between groups.
Table 1b depicts that more than half, 65% of the women in experimental group and 50% in
control group have no support system. The entire population 100% of the women in both
groups did not follow any other alternative system of medicine. Majority of the women, 85%
in the experimental group and 80% women in control group had natural menopause. The t-
value is 0.01 and the level of significance is 0.001 which is highly significant. More than half
55% of the women in experimental group have an above normal BMI, whereas 45% women
in control group have a normal BMI.
52
SECTION 2a: FINDINGS RELATED TO THE ASSESSMENT OF
MENOPAUSAL SYMPTOMS BEFORE, DURING AND AFTER THE
INTERVENTION IN THE EXPERIMENTAL AND CONTROL GROUP
TABLE 2: Range, mean, standard deviation of pre, mid and post test scores of
menopausal women in experimental and control group.
n= 40
Test scores Max score Range Mean / S. D Test of p- value

significance
Pre – test
scores
Experimental 130 23-73 46.00±13.64 0.219 0.828
Control 130 21-80 45.00±15.18 NS
Mid- test
scores
Experimental 130 5-56 31.15±15.22 2.311 0.026**
Control 130 19-76 42.50±15.84
Post- test
scores
Experimental 130 9-51 29.50±14.42 2.630 0.012**
control 130 19-76 42.50±15.96
** Highly significant NS not significant Independent t – test is used
Table 2 depicts that the mean/SD of the post test scores in the experimental group is
29.50±14.42, the mid-test score is 31.15±15.22, which is significantly lesser than the
pre-test score 46.00±13.64 and the level of significance of the change is 0.02 for mid-
test and 0.01 for the post-test scores in the experimental group. The control group has
a mean and SD of 45.00±13.64, 42.50±15.84, 42.50±15.96 for the pre, during and
post- test respectively.
53
SECTION 2b: FINDINGS RELATED TO THE ASSESSMENT OF
MENOPAUSAL SYMPTOMS BEFORE, DURING AND AFTER THE
INTERVENTION IN THE EXPERIMENTAL AND CONTROL GROUP-
SYMPTOM WISE
n=40
9
7.9
8
7 6.3
5.85
6
6.35
5
exp
4 5.05
control
4.55
3
0
pre mid post
Figure4: Findings of hot flashes before, during and after the intervention in the
Figure 4 shows that the mean post-test scores of hot flashes (4.55), mid-test score
(5.05) in the experimental group is significantly lesser than pre- test score (7.9)
whereas the pre, mid and post-test scores of hot flashes in the control group are 6.35,
6.3, 5.85 respectively. The significance of the corresponding variables, hot flashes is
significant over a period of time (<0.001) and also in comparison between two groups
is (0.001). The corresponding F statistics for time effect is 40.76 and interaction effect
is 26.96.
54
n=40
8
7
7 6.2 6.4
6
6.55
5
4 exp
4.6
4.2 control
3
0
pre mid post
Figure 5: Findings of sweats before, during and after the intervention
in the experimental and control group
Figure 5 depicts that the mean pre-test score of sweats in the experimental
group is 7, higher than the mid-test score which is 4.6 and post-test score
is 4.2 . The pre-test, mid-test and post-test scores of sweats are 6.55, 6.2
and 6.4 respectively in the control group. The significance of the time
effect and interaction effect of the corresponding variables is < 0.001. The
F statistics for the time effect is 33.74 and interaction effect is 23.78.
55
n=40
3.5
3 2.9
2.5
2.5
2.4
2
exp
1.5 control
1.6
1
1.1 1.25
0.5
0
pre mid post
Figure 6: Findings of sleep disturbances before, during and after the
intervention in the experimental and control group
Figure 6 clearly shows that the mean pre-test scores of sleep disturbances is 2.9, mid-
test 2.5, post-test scores 2.4 in the experimental group and the sleep disturbances mean
pre-test scores is 1.1, mid-test scores is 1.25, post-test scores is 1.6 in the control
group.
56
n=40
7
6.05
6
5 5.6
4.7
4
exp
3 3.9 control
3.45
2
1
0.5
0
pre mid post
Figure 7: Findings of fatigue before, during and after the intervention in the
Figure 7 depicts that the fatigue mean pre-test score is 5.6, mid-test score 3.9 and post-
test score 3.45. It is identified that in the control group the pre, mid and post-test
scores are 6.05, 0.5 and 4.7 respectively. The significance of the time effect of the
corresponding variable is <0.001 and for the interaction effect it is 0.374. The
corresponding F statistics for time and interaction effect is 18.73 and 0.374
respectively.
57
n=40
1.6
1.4 1.5
1.2
1
0.7 exp
0.8 0.8
control
0.6
0.4
0.5
0.45
0.2
0 0.15
pre mid post
Figure 8: Findings of vaginal dryness before, during and after the intervention
The line diagram in figure 8 depicts that the vaginal dryness mean pre-test score is
0.45, mid-test score 0.15 and post-test score 0.5 in the experimental group. The trend
in the pre, mid and post- test score of vaginal dryness in the control group is 0.7, 0.8
and 1.5 respectively.
58
n=40
4
3.6
3.5
3.5
3 2.85
2.5
2.7
2 exp
2.2 2.2 control
1.5
0.5
0
pre mid post
Figure 9: Findings of depression before, during and after the intervention in the
Figure 9 shows that depression mean pre-test score is 2.7, mid-test score and post-test
score is 2.2 in the experimental group. The mean depression scores in the control
group during pre, mid and post- test are 3.6,3.5 and2.85 respectively, which is on a
downward trend.
59
n=40
3
2.65
2.5 2.65
2.5
2 2.3
1.5 1.9 exp

1.85
control
1
0.5
0
pre mid post
Figure 10: Findings of headache before, during and after the intervention in the
Figure 10 depicts that the headache scores pre-test score is 2.3, mid-test score is 1.9
and post-test score is 1.85 in the experimental group. The pre-test score is 2.5, the mid
and post-test headache score is 2.65 in the control group.
60
n=40
5 4.8 4.6
4 4.6
4.3
3 exp
3.25 control
3.15
2
0
pre mid post
Figure11: Findings of irritability before, during and after the intervention in the
Figure 11 depicts that the irritability pre, mid and post-test scores are 4.3, 3.25 and
3.15 respectively which is not much of a large difference in the experimental group. A
score of 4.8 is the pre- test score in the control group, the mid- test and post- test score
for irritability is 4.6.
61
n=40
8
7.2
7 6.5
6 6.35
4 exp
4.5 control
3 3.9
2
0
pre mid post
Figure 12: Findings of muscle/joint pain before, during and after the intervention
Figure 12 depicts for muscle/ joint pain depicts that the mean pre-test score is 7.2,
mid-test score is 4.5, and post-test score is 3.9 in the experimental group, which is a
strong downward trend showing a rapid reduction. On the contrary, the pre- test score
is 7.2, mid- test score is 6.5 and post-test score is 6.35 in the control group. The
significance of the corresponding variable for the time and interaction effect is <
0.001. The F statistics for the time effect and interaction effect is 42.16 and 14.66
respectively.
62
n=40
1.8
1.65
1.6
1.35
1.4
1.3
1.2 1.45
1 1.2
exp
0.8 1.05
control
0.6
0.4
0.2
0
pre mid post
Figure 13: Findings of nervousness before, during and after the intervention in
the experimental and control group.
Figure 13 for nervousness depicts that the mean pre-test score is 1.65, mid-test and
post test scores in the experimental group are 1.35 and 1.3 respectively. The mean pre,
mid and post- test scores in the control group are 1.45, 1.2, 1.05 respectively. The
trends are more or less similar in both groups.
63
n=40
3.5
2.95 2.95 3.15
3
2.5
2.3
2
exp
1.5 control
1.6
1
0.5 0.9
0
pre mid post
Figure 14: Findings of palpitations before, during and after the intervention in
the experimental and control group
Figure 14 for palpitations depicts that the pre, mid and post-test scores in the
experimental group are 2.3, 0.9 and 1.6 respectively. The pre and mid-test scores are
similar 2.95 and post- test scores are 3.15 in the control group
64
n=40
1.4
1.3
1.2
1.25 1.15
1.2
1
0.8
exp
0.6 0.75 control
0.65
0.4
0.2
0
pre mid post
Figure15: Findings of dizziness before, during and after the intervention in the
Figure 15 depicts that dizziness pre- test score is 1.3, mid-test score is 0.75 and post-
test score is 0.65 in the experimental group. It is identified that in the control group the
pre, mid and post- test scores are 1.25, 1.2, and 1.15 respectively.
65
n=40
0.6
0.5
0.5
0.4 0.35
0.4 0.3
0.3 exp
control
0.2
0.1
0.1 0.1
0
pre mid post
Figure 16: Findings of breast tenderness before, during and after the
intervention in the experimental and control group
Figure 16 depicts that the breast tenderness pre, mid and post-test scores are 0.4, 0.1
and 0.1 respectively in the experimental group. The control group scores are 0.5, 0.35,
and 0.3 respectively.
66
SECTION 3
TABLE 3: Findings related to association between menopausal symptoms and

selected baseline variables
n= 40
S.NO Baseline Experimental Test of p- Control group Test of p-

variables significance value significance value
Mean /S.D Mean/S.D
1 Duration
of
menopause
1-3 44.72±13.5 1.16 0.338 43±15.37 1.12 0.350
4-6 53.4±15.07 ANOVA NS 57±20.22 ANOVA NS
7-10 40.25±11.02 42.71±12.39
2 Education
Illiterate 46.90±15.28 0.90 0.426 42.25±14.66 0.47 0.635
School 50.2±10.82 ANOVA NS 50±15.73 ANOVA NS
>school 38.25±11.44 40.5±23.33
3 Occupation
Unskilled 47.93±13.76 1.293 0.212 44.06±13.31 0.466 0.646
Others 38.25±11.44 t- test NS 47.8±23.38 t- test NS
4 Marital
status
Married 49.06±13.00 1.849 0.081 44.25±13.39 0.432 0.670
Others 36.8±12.27 t-test NS 48±23.38 t- test NS
5 Support
system
Yes 46.42±12.81 0.100 0.921 45.1±12.00 0.029 0.977
No 45.76±14.56 t- test NS 44.9±18.49 t- test NS
6 Type of
menopause
Natural 46.35±13.79 0.269 0.791 45.62±16.43 0.360 0.723
Surgical 44±15.39 t- test NS 42.5±9.84 t- test NS
7 BMI
<=18.5 44.33±13.27 0.03 0.972 32±15.55 1.44 0.265
18.5-23.5 45.83±16.04 ANOVA NS 42.66±14.84 ANOVA NS
>=23.5 46.54±13.72 50.22±14.74
NS non-significant.
There is no significant difference between duration of menopause, education,
occupation, marital status, support system, type of menopause, BMI and the pre- test
scores.
67
6. DISCUSSION
Women go through a complex phase of menopause, most often between 45 and 55
years. The declining oestrogen levels are mainly responsible for the menopausal
symptoms. Besides, physical activities, social as well as environmental factors have
significant impact. Management of menopause therefore needs a holistic approach. It
needs to be treated with a multidisciplinary approach, whereby clinical care, lifestyle
changes and family support are necessary9. The present study aims, to assess the
effectiveness of soya bean on menopausal symptoms among women working in St.
John’s National Academy of Health Sciences– Bangalore.
OBJECTIVES OF THE STUDY
Discussion of the present study is organized under the following sections
Section 1: Findings related to baseline variables
Section 2: Findings related to the assessment of menopausal symptoms before, during
and after the intervention in the experimental and control group
Section 3: Findings related to association between menopausal symptoms and selected
baseline variables
68
Section 1: Findings related to baseline variables
Lesser the duration of menopause greater the symptoms as already stated theoretically.
The present study has taken women with a duration of menopause up to 10 years
though nearly half of the subjects in the present study 55% of women had a duration
of 1-3 years of menopause in the experimental group and 50% had a duration of 1-3
years in control group. In a similar study done in Tamil Nadu 83.33% of the samples
were between 51- 55 years of age, but there was no calculation of the duration of their
menopause, but it implies that women with a duration of 5 years of menopause were
only taken57. A similar study done in Oklahoma took age as a baseline variable and
the mean age was 56 and years since menopause was six66. A study done in Brighton
showed that 53.8 was the mean age at menopause and 4.7 years was the mean duration
of menopause63, which is in contrast to our present study.
A study done in Manipal depicted that the mean age at menopause was 46.158.
Albertazzi’s study showed that the age of the subjects in the experimental group was
53.369. A study done among Asian women showed that 55 years was the median age62.
In a similar study done in Mumbai average age was 51.5 years9. A similar study done
in USA showed that 48.2 was the mean age at menopause61.
The more educated the women are, the more knowledge they have on the menopausal
problems which in turn would help them cope with it more effectively and react
negatively to it to a lesser extent. Educational status among the women was illiteracy
for 55% women in experimental and 60% in control group in the current study. In the
study done in Tamil Nadu 93.33 per cent in the experimental group were illiterate and
83.33 % were illiterate which is similar to our present study57.
69
Majority 75% of the women were married in the experimental group and 80% were
married in the control group, which is similar to a similar study done study done in
Tamil Nadu where 90% in experimental group and control group were married57.
The study done in Brighton depicted that the subjects in the experimental group had a
BMI of 26.5 which was above the normal limits63. Albertazzi’ s study BMI was 25.9
which is above the normal and similar to our present study69. The Okhalma study
findings on BMI were 27.3 which were above the normal66. The study conducted in
the USA showed that the BMI was 25.4 which was above normal61. The findings
related to the BMI of the above studies are very similar to the present study were 55%
of the women in experimental group had an above normal BMI, whereas 45% women
in control group had a normal BMI and 45% in control group had an above normal
BMI.
The study among Asian women showed that the population was thin with a BMI of
23.2 which is in contrast to the present study where all the clients had an above normal
BMI62.
Women with surgical menopause are prone to more severe menopausal symptoms.
The Mumbai based study showed that number of women who underwent surgical
menopause was 30 out of 70 cases9. In a study done in Indiana 12 women had natural
menopause and one had surgical menopause64, which is all similar to the present
study where majority of the subjects(85%) had natural menopause and only a small
number (15%) had undergone surgical menopause.
In a study done in Manipal, eight of the subjects had natural menopause and 23 in that
study underwent surgical menopause which is in contrast to our present study
findings58.
70
It is believed that women with a good support system or a woman following any
alternative system would have lesser symptoms. The present study also depicts that
65% of the women in experimental group and 50% in control group had no support
system. It is also to be noted that none of the subjects used any alternative system of
practice. 2 out of 40 subjects followed stress reduction techniques like walking,
singing, dancing, talking to friends and listening to music whereas the rest practiced
none.
Section 2: Findings related to the assessment of menopausal
symptoms before, during and after the intervention in the
In this study mean pre- test, mid- test and post-test scores were 46.00, 31.15 and 29.50
respectively. The post-test score (29.50) was 16.5 points lesser than the pre-test
score(46.00) and 14.85 points lesser than the mid-test score (31.15) in the
experimental group. The level of significance was 0.828, 0.026 and 0.012 for the pre,
during and post-test scores. In a similar study which was done in Tamil Nadu the
mean post- test status of the selected menopausal problem is 13.5 lower than the mean
pre- test status of selected menopausal problems of 18.03. The obtained t value was
12.58 and was statistically significant at 0.0557. A study done in Manipal to evaluate
the effectiveness of soy isoflavnone therapy on menopausal symptoms wherein the
subjects received 75mg soy isoflavnone tablets daily for 12 months showed that
during the treatment period, the menopausal symptoms of the participants were
significantly lower than the baseline. The improvement in the Kupperman index
became statistically significant from the third month onwards and remained so till the
end of the study. The level of significance was <0.001 at the 3rd, 6th and 12th month
71
respectively. The Kupperman index, in addition to the scale used in the present study,
assessed for symptoms like paraesthesia and formication. Paraesthesia showed a
reduction significantly, whereas no one reported formication58.
The study done in Massachusetts to find the association between soy nut consumption
and decreased menopausal symptoms wherein the experimental group received a pre-
packaged allowance of one- half cup of unsalted soya nuts divided into 3 or 4 portions
throughout the day. After 4 weeks the groups were crossed over. This was continued
for 8 weeks after which they were assessed. Compared to the TLC diet alone, the TLC
diet plus soy nuts was associated with a 45 % decrease in hot flashes ( 7.5± 3.6 vs. 4.1
± 2.6 hot flashes, respectively, p< 0.001) in women with > 4.5 hot flashes/ day at
baseline and 41% in those with <= hot flashes/ day(2.2±1.2 vs. 1.3±1.1, p<0.001) soy
nut intake was also associated with improvement in scores in the MENQOL
questionnaire; 19 % decrease in vasomotor score(p=0.004), 12.9% reduction in
psychosocial score(p=0.01), 9.7% decrease in physical score(p=0.045) and a trend
towards improvement in sexual score, with a 17.7% reduction(p=0.129)60. The trend
of the improvement of symptoms was positive, they have used just 25 gram of soy
protein which is feasible to incorporate into the diet in populations unaccustomed to
consuming soya and in these two aspects it is similar to our present study. The time
period of the present study was in contrast to this study wherein the intervention was
for 8 weeks and our study was 4 weeks. TheMassachusetts study concentrated on the
holistic aspects of women, whereas the present study was concentrated on vasomotor
symptoms which are in contrast. In conclusion, soy nut ingestion was associated with
a significant decrease in hot flashes and menopausal symptoms in postmenopausal
women.
72
Another study conducted in Canada showed reductions from baseline in LDL
cholesterol and Apo lipoprotein in equol producers compared with reductions in non-
producers. The effect of daily soy supplementation for 3 months showed that the total
and subcutaneous abdominal fat increased more in the placebo compared to the soy
group59. A study in Birmingham also showed that a daily supplementation of soy
protein reduces the gain in total abdominal and subcutaneous fat in postmenopausal
women65. In the present study there was no assessment of blood cholesterol but there
was 0.5 kg weight reduction among 10 subjects, 1 kg reduction in 1 subject and 5 kg
reduction in 1 subject in the experimental group. The remaining clients had the same
weight; there was one client with 0.5 kg increase in weight after a month. The women
also reported a feeling of lightness and a feeling of being healthier after the
consumption of soya for a month.
Benefits of soy isoflavnone therapeutic regimen on menopausal symptoms and
cardiovascular risk factors in response to 4 months of daily 100 mg soy isoflavnone in
postmenopausal women showed a decrease in menopausal symptoms between
baseline and isoflavnone groups, and between placebo and isoflavnone groups. Total
cholesterol and LDL decreased significantly in the isoflavnone group compared with
the baseline or placebo group (p<.001), between baseline and isoflavnone groups and
p<0.01 between placebo and isoflavone group. The study showed a positive effect on
the cardiovascular system. In the present study there was a 0.7 reduction in the mean
palpitation score among women in the experimental group after the intervention67.
Albertazzi’ s study showed that 60 gram of soy was significantly superior to placebo
60 gram of placebo in reducing the mean number of hot flushes per 24 hours after 4, 8
and 12 weeks at 0.01 level of significance. In particular, women taking soy had a 26 %
reduction in the mean number of hot flashes by week 3 and a 33% reduction by week
73
four. By the end of the 12th week patients taking a soy had a 45% reduction in their
hot flashes versus a 30 % reduction obtained with a placebo (p<0.01). In the present
study there was a 16.25 reduction in symptoms among mean post-test scores from the
pre- test scores at a level of p< 0.01 significance. There was a 3.55 reduction in the
mean hot flash post- test score (4.55) from the pre- test score (7.9).the effect became
significant within the first two weeks of treatment which is similar to our present
study69.
A vegetable fruit soy dietary pattern showed a decreasing trend of breast cancer
among postmenopausal women with a >= 5 year follow up. The present study just
administered soya and jaggery and no other combinations and breast cancer trends
were not assessed, however breast tenderness was reduced, which reduced by 0.3 from
the mean pre- test score(0.4)62.
In another study done in Brighton Australia after the experimental group was exposed
to 12 weeks of 45g soya flour supplementation, the flush score decreased significantly
within 6 weeks and a further significant decrease occurred in weeks 6- 12 with a total
flush reduction of 40 %. The wheat flour supplemented group had an unchanged flush
score for the first 6 weeks but significantly decreased between 6-12 weeks with a
decrease of 25 %. There was no significant difference between the two flours
(p=0.82). This was quite in contrast to the present study wherein there is a 0.01 level
of significant difference between the experimental and control group63.
For the individual symptoms repeated measures of ANOVA could not be applied to all
symptoms because of small values and minute variations. However for hot flushes,
sweats, fatigue and muscle/ joint pain repeated measures of ANOVA was applied and
74
it was statistically significant at the level of 0.001 for hot flashes, sweats and muscle/
joint pain.
Thus the hypothesis that there is a significant change in the menopausal symptoms
between experimental and control group was accepted.
Section 3: Findings related to association between menopausal symptoms and
selected baseline variables
In the present study there was no association between pre- test scores and baseline
variables.
Albertazzi‘s study was well balanced with respect to baseline characteristics and there
was no statistically significant difference between baseline values in the two groups or
between centres69. Oklahoma university‘s study showed that women in both treatment
groups had similar baseline variables66. In a study done in Birmingham demographic
characteristics of study volunteers at baseline of soy and placebo groups were not
significantly different with regard to any baseline variable which is similar to the
present study65.
The mean scores were higher in the one to six years duration; this could be because of
the fact that menopausal symptoms are higher during the immediate menopausal
period and gradually fade away.
There is a trend of higher mean symptoms in the lesser educated as compared to the
well-educated. This could be attributed to the fact, more educated people have a better
knowledge about the symptoms and therefore they are able to cope in a better way
compared to less educated people. Unskilled participants had higher mean scores
75
compared to other categories which mainly could be because of their corresponding
low educational status.
Married women had higher mean scores than other categories which could be because
of the fact that married women have additional responsibilities and stress when
compared to other categories of participants.
Women with natural menopause had more severe symptoms compared to surgical
menopause; this could be attributed to the fact that women who underwent surgical
menopause were in a longer duration of menopause than the women in natural
menopause.
People with above normal BMI had greater symptoms, which could be because of the
fact that obesity leads to a greater basal metabolic rate compared to their normal
counterparts.
76
7. CONCLUSION
Climacteric is derived from the Greek word “ critical point in human life”, indicating
the period of time when a woman passes through transition from the reproductive
stage of life to postmenopausal years, which is an important time in women’ s life.
Many women make the menopausal period as a fruitful one by managing menopausal
symptoms and preventing complications. The nurse’s involvement in understanding
the changes in women will be able to bring about the changes in the life of women.
Women have a pivotal role in the family and society and during the menopausal
phase, additionally she faces a lot of physical, psychological and social challenges
mostly because of changes in hormonal levels andcuration of gonadal function. In
spite of this burden, an individual woman strives to live her normal day to day life.
Menopause being a sensitive issue, women do not open up about it, they end up with
severe illness, but they don’t seek help. Thus as health care professionals one should
bear in mind the need to help all women in this age group. The information should
reach all women who are expecting to attain menopause, who are in transitional phase
between pre and post menopause and who have already attained menopause.
The present study was conducted to assess the effectiveness of soya bean on
Health Sciences– Bangalore
77
Major findings of the study
Findings related to baseline variables
Half of the women 55% had a duration of 1-3 years of menopause in the experimental
group and 50% in control group also had a duration of 1-3 years. Educational status
among the women was illiteracy for 55% women in experimental and 60% in control
group. Most of the women 80% in the experimental and 75% in control group were
unskilled. Majority of the subjects 75% were married in the experimental group and
80% were married in the control group. There was no significant difference between
selected baseline variables in the control and experimental group.
More than half 65% of the women in experimental group and 50% in control group
had no support system. Support system is 35% in the experimental group and 50% in
the control group. The entire population 100% of the women in both groups did not
follow any other alternative system of medicine. Majority of the women 85% of the
women in the experimental group had natural menopause and 80% women in control
group had natural menopause. The t- value was 0.01 and the level of significance was
0.001 which is highly significant. More than half 55% of the women in experimental
group had an above normal BMI, whereas 45% women in control group had a normal
BMI and 45% in control group had an above normal BMI.
78
Findings related to effectiveness of soya bean on menopausal symptoms
whereas the mid-test score was 31.15±15.22, which was significantly lesser than the
mid-test and 0.01 for the post-test scores in the experimental group. The control group
had a mean and SD of 45.00±13.64, 42.50±15.84 and 42.50±15.96 for the pre, during
and post- test respectively. The above means that soya bean was effective in reducing
menopausal symptoms in comparison with the placebo at 0.001 level of significance.
The mean post-test scores (4.55), mid-test score(5.05) of hot flashes in the
experimental group was significantly lesser than pre- test score(7.9) whereas the pre,
mid and post-test scores in the control group were 6.35, 6.3 and 5.85 respectively.The
significance of the corresponding variables, hot flashes was significant over a period
of time (<0.001) and also in comparison between two groups (0.001). The
corresponding F statistics for time effect is 40.76 and interaction effect was 26.96.
For sweats pre-test score in the experimental group was 7, higher than the mid-test
score which was 4.6 and post-test score was 4.2 . The pre-test, mid-test and post-test
scores were 6.55 6.2 and 6.4 respectively in the control group.The significance of the
time effect and interaction effect of the corresponding variables was < 0.001. The F
statistics for the time effect is 33.74 and interaction effect was 23.78.
The sleep disturbances mean pre-test scores was 2.9, mid-test 2.5 and post-test scores
2.4 in the experimental group.The mean pre-test scores was 1.1, mid-test scores 1.25
and post-test scores was 1.6 in the control group.
That fatigue rating showed that the mean pre-test score was 5.6, mid-test score 3.9 and
post-test score 3.45. It was identified that in the control group the pre, mid and post-
79
test scores were 6.05, 0.5 and 4.7 respectively. The significance of the time effect of
the corresponding variable was <0.001 and for the interaction effect 0.374. The
corresponding F statistics for time and interaction effect were 18.73 and 0.374
respectively.
Vaginal dryness mean pre-test score was 0.45, mid-test score 0.15 and post-test score
0.5 in the experimental group. The trend in the pre, mid and post- test score in the
control group was on the rise 0.7, 0.8 and 1.5 respectively.
Depression mean pre-test score was 2.7, mid-test and post-test scores were 2.2 in the
experimental group. The mean depression scores in the control group pre, mid and
post- test were 3.6, 3.5 and 2.85 respectively, which was on a downward trend.
For head ache the experimental group had a pre-test score 2.3, mid-test score of 1.9
and post-test score of 1.85. The pre-test score was 2.5; the mid and post-test scores
were 2.65 in the control group.
The irritability pre, mid and post-test scores were 4.3, 3.25 and 3.15 respectively
which was not much of a large difference in the experimental group. A score of 4.8
was the pre- test score in the control group, whereas the mid- test and post- test score
were 4.6.
The muscle/ joint pain mean pre-test score was 7.2, mid-test score 4.5, and post-test
score 3.9 in the experimental group, which had a strong downward trend showing a
rapid reduction. On the contrary, the pre- test score was 7.2, mid- test score 6.5 and
post-test score was 6.35 in the control group.The significance of the corresponding
variable for the time and interaction effect was < 0.001. The F statistics for the time
effect and interaction effect were 42.16 and 14.66 respectively.
80
The nervousness mean pre-test score was 1.65, mid-test and post test scores in the
experimental group were 1.35 and 1.3 respectively. The mean pre, mid and post- test
scores in the control group were 1.45, 1.2, 1.05 respectively. The trends were more or
less similar in both groups.
Palpitations pre, mid and post-test scores in the experimental group were 2.3, 0.9 and
1.6 respectively. The pre and mid-test scores were similar 2.95 and post- test scores
were 3.15 in the control group.
For dizziness the pre- test score was 1.3, mid-test score 0.75 and post-test score 0.65
in the experimental group whereas in the control group the pre, mid and post- test
scores were 1.25, 1.2, 1.15 respectively.
The symptom breast tenderness pre, mid and post-test scores were 0.4, 0.1 and 0.1
respectively in the experimental group, the control group scores were 0.5, 0.35 and 0.3
respectively.
Findings related to association of baseline variables with menopausal symptoms
There was no significant difference between the two groups and there was no
association between baseline variables and pre- test scores.
To conclude soya bean was effective in reducing menopausal symptoms among
women going through menopause with a duration of ten years. It’s a cheap, simple
and effective method to help women cope with troublesome symptoms with a cure
home based and naturally.
81
IMPLICATIONS OF THE STUDY
The study reveals an improvement in the menopausal symptoms in women with a
duration of maximum 10 years of menopause. This indicates the importance of
imparting knowledge about the miracle bean – soya; to women going through these
symptoms. Nurses play an important role in history collecting and imparting
knowledge to patients, so they can help out women going through this tough phase.
The study findings will help to implement several practical and safe implications in
the field of education, nursing administration and nursing research.
Nursing education
Midwifery is one of the most important subjects of the curriculum. The future nurses
should play a major role in the preventive and promotive aspect of women’s health.
Nurses should take responsibility of identifying women in our society who are silently
suffering from these menopausal symptoms. Waken these women to the fact that there
are several alternative and complementary therapies that are less harmful than their
hormonal counterparts and which could bring amazing results that improve their
quality of life. Nurses should understand if women are following any alternative
system or complementary therapies to reduce their symptoms and they should
countercheck if these therapies are safe enough. They should also educate women
about contemporary therapies that are proved effective with a strong evidence base
and are safe to adhere to.
82
Nursing administration
The nursing administrative department can have an alternative and complementary
medicine consultant and a committee in the hospital to which patients could be
referred to if they are following or if they would like to follow this contemporary style
of treatment. The committee could also provide periodic in service education to health
care personnel regarding the effectiveness of alternative and complementary therapies.
Nursing research
The modern world gives great importance to evidence based practice. Research plays
an important role in strengthening our professional and knowledge base. Therefore
indeed further studies should be done in the area of reducing menopausal symptoms
by contemporary styles of medicine practice and its effectiveness should be proved.
Therefore life would become healthier and easier with earth’s natural marvels.
Nursing practice
Nurses are meant to care. They are important members of the health team that patients
are very comfortable interacting with. Therefore nurses should use their knowledge
and skill in identifying women with menopausal symptoms and identify their system
of remedy and get it across to them regarding whether their remedies are safe and
what could be other proven alternatives that would help them alleviate their
symptoms.
83
LIMITATIONS
The limitations recognized in the study are:
 The study was limited to SJNAHS- Bangalore, which limits its generalization.
 The subjects who were on leave were given the laddu in prior, with
instructions to eat it, but the researcher did not have any control on whether
they were actually taking it or not, though it was counter checked with the
participants on the next working day.
 The data collection period was reduced to thirty days after the pilot study.
 It was difficult to acquire participants for the study as they were not willing to
consume the laddus for thirty continuous days.
 Survey of the entire population was not possible as many of them were not
willing or they were busy with their work.
RECOMMENDATIONS
 A similar study can be done with a larger sample
 The study can be conducted to assess the effectiveness of soya in weight
reduction in menopausal women
 A similar study can be repeated in the rural setting
 A similar study can be done for a period of 15 days.
 A comparative study to assess the effectiveness of wheat and soya in reducing
menopausal symptoms can be done.
84
8. SUMMARY
The present study was undertaken to assess the effectiveness of soya bean on
Health Sciences– Bangalore.
The objectives of the study were
The study attempted to examine the following research hypothesis
 H1- There is a significant change in menopausal symptoms between
 H2- There is an association of menopausal symptoms before soya bean
intake with baseline variables.
Assumptions made for the study were
 Women in menopause may present with vasomotor symptoms
 Soya bean may have a therapeutic effect on menopausal symptoms
It was found that Imogene King’ s goal attainment theory was very much apt for the
study as it deals with perception, interaction, transaction ,communication which were
85
all important aspects used in the study. Complementary therapy of soya bean was
found effective in reducing menopausal symptoms which was statistically significant.
Review of literature was focussed towards menopause and its problems, alternative
therapies for menopausal symptoms and soy and soy isoflavnones used for
menopause.
The research approach was a randomized controlled trial having 2 groups; one
experimental and the other control. The study subjects comprised of 40 samples
selected from the working women in St. John’ s National Academy of health sciences-
Bangalore based on simple random sampling technique.
Data collection instrument consisted of demographic proforma for collection of
baseline variables and the Wiklund vasomotor symptom scale. The tool was a
standardized tool. Ethical clearance was taken from the institutional review board. The
pilot study was conducted to test the feasibility of the study. The need for the study
was explained and informed consent was obtained before the intervention. The data
thus gathered was analysed and interpreted in terms of objectives using descriptive ad
inferential statistics.
whereas the mid-test score was 31.15±15.22, which were significantly lesser than the
mid-test and 0.01 for the post-test scores in the experimental group. The control group
had a mean and SD of 45.00±13.64, 42.50±15.84, 42.50±15.96 for the pre, during and
post- test respectively.
86
The above findings showed that soya bean is an effective method to reduce
menopausal symptoms. Nurses should take an active role in introducing this
alternative therapy in improving the health and wellbeing of women especially the
women going through climacteric.
In general the process of the study was memorable and an excellent learning
experience for the investigator. It has given the investigator an in-depth and wealth of
information on the subject matter. The investigator also firmly believes that this
information would be a valuable and important piece of information for women in the
brink of their menopause.
87
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10.ANNEXURES
ANNEXURE- 1
Letter to the director seeking permission to conduct the study
96
97
98
99
100
ANNEXURE- 2
Letter seeking IERB ( Institutional Ethical Review Board ) approval
101
ANNEXURE- 3
Certificate of IERB ( Institutional Ethical Review Board) approval
102
ANNEXURE- 4
Certificate of clearance from the nutritionist
103
104
105
ANNEXURE- 5
Letter seeking expert opinion on editing the research thesis
From
Monica Rita Hendricks,
2nd year M.Sc. Nursing student
St. John’s College of Nursing,
Bangalore- 560034.
To
Mrs.SiromonyNirmala Rani MA, MPhil, (PhD.)
Department of English,
Sacred Heart Convent AIHS School -Villupuram
Forwarded through
The Principal,
St. John’s college of Nursing,
SJNAHS, Bangalore- 34.
Subject: - Seeking Expert Opinion on Editing the Research Thesis
Respected madam,
I Monica Rita Hendricks, doing II year MSc Nursing (Obstetrics and Gynaecological
Nursing specialty) at St. John’s college of nursing, Bangalore, request your expert
opinion in editing of the research content. The topic selected for the dissertation is,“A
Study to assess the effectiveness of soya bean on menopausal symptoms among
women working in St. John’s National Academy of Health Sciences–
Bangalore”,as a partial fulfilment for M.Sc. Nursing Degree programme at Rajiv
Gandhi University of Health Sciences, Bangalore.
I kindly request you to give your valuable suggestions with regard to the editing of English
literature aspect. I also request you to kindly sign the editing certificate and would be highly
obliged and grateful to hear from you at the earliest.
Thanking you in anticipation,
Yours sincerely,
Monica Rita Hendricks.
MSc Nursing student.
106
ANNEXURE-6
CERTIFICATE OF EDITING
This is to certify that research thesis done by Monica Rita Hendricks, ll year MSc Nursing
student in St. John’s College of nursing, Bangalore, titled “A Study to assess the
effectiveness of soya bean on menopausal symptoms among women working in St. John’s
National Academy of Health Sciences– Bangalore” has been edited byme.
She has to make no/few/many modification before printing the book.
107
ANNEXURE-7
PATIENT INFORMATION SHEET
The investigator, Ms. Monica Rita Hendricks, 1st year MSc Nursing student, is doing a
study to “ Assess the effectiveness of soya bean in reducing menopausal symptoms
among working women in St John’s National Academy of Health Sciences -
Bangalore.” as a part of the partial fulfillment of her Master’s degree under the Rajiv
Gandhi University of Health Sciences, Bangalore.
You are invited to participate in the study, provided you are willing to do so. There is
absolutely no compulsion involved. The study is on the effect of soya bean to reduce
menopausal symptoms, wherein a 25 gram soya bean laddu would be given to the
experimental group and 25 gram rice laddu would be given for the control group for a
duration of thirty days. Soya bean has been proven effective and safe in reducing
menopausal symptoms.
The investigator intends to include all menopausal women (natural/ surgical- after 2
weeks have elapsed) with two or more symptoms in the study. Subjects with diabetes
mellitus, renal problems and thyroid conditions and known food allergies would be
excluded.
There will be two groups – the experimental group and the control group. The subjects
will be randomly selected. The control group will be given one rice laddu 25 gram
daily for a duration of thirty days, while the experimental group will receive one 25
gram soya bean laddu daily for a duration of thirty days. In both groups, menopausal
symptoms would be assessed before, on the fifteenth day and on the thirtieth day.
There is absolutely no harm associated with this study. It does, however, require
patience and co-operation on your part. You have the right to withdraw from the study
at any time and your decision is and will be duly respected. You can remain secure in
the fact that all information you divulge will be kept strictly confidential.
Thank You
Date: Signature of the investigator
108
ANNEXURE-8
INFORMED CONSENT
I, __________________, aged ______ years, hereby state that I have been told by the
investigator about the study and that I would be given a soya bean laddu or rice laddu
to reduce my discomfort and also that the severity of the symptoms would be assessed
before , during and after the intervention is administered with the help of a scale to
which I have to respond. I have no objection and I agree to be enrolled in this study.
I am aware that I am permitted to withdraw from the study at any point and
withdrawal or refusal to consent will no way affect my job in this hospital.
I willingly consent to be a participant in this study.
Signature / thumb impression
Place:
Date:
Witness:
109
ANNEXURE- 9
RESEARCH TOOL
A study to assess the effectiveness of soya bean on menopausal symptoms among

women working in St. John‘s National Academy of Health Sciences – Bangalore.
OBJECTIVES:

2. To determine the association between menopausal symptoms before
intervention with baseline variables.
SECTION – A
BASELINE VARIABLES:
Instruction to the interviewer:
The interviewer is to ask the following questions to the respondents. Allow the
respondents to answer. She can place a ( ) on the option according to the answer
stated by the respondent.
IDENTIFICATION DATA:
Age in years:
Education: illiterate / till sslc / higher secondary/ graduate and above
Occupation: professional/ semi- professional/ clerical/ skilled worker/
unskilled worker
Marital status: single/ married/ divorced/ widowed/ religious
Age at menopause:
Type of menopause: natural/ surgical (after 6 weeks)
Do you have any of the following?
110
 Diabetes mellitus yes/no
 Thyroid problems yes/ no
 Renal problems yes/ no
Are you on hormone replacement therapy? Yes/ no
Do you consume soya bean regularly? Yes/ no
BMI : Weight-
Height-
How many of the following symptoms do you face ?
(Sweats, hot flushes, sleep disturbances, fatigue, vaginal dryness, depression,

headache, irritability, muscle/ joint pain, breast tenderness, nervousness)
111
TOOL
SECTION - A
BASELINE VARIABLES:
Instruction to the interviewer:
The interviewer is to ask the following questions to the respondents.

Allow the respondents to answer.
IDENTIFICATION DATA:
Age in years:
Education:
Occupation:
Marital status:
Height:
Weight:
BMI:
Age at menopause:
Type of menopause:
Support system:
Any other alternative therapy practice:
Any other stress reduction technique practice:
112
SECTION – B:
STUDY ID:
TIME POINT: BEFORE/ 15 DAYS/ 30 DAYS
DATE:
Please complete this checklist.
Day of the week checklist completed:

Monday Tuesday Wednesday Thursday Friday Saturday Sunday
For each symptom, fill in the circle that indicates the severity of this symptom for you
during the past week rated on a zero (None) to 10 (Very Severe) scale.
Symptom SCALE
None Severe
0 1 2 3 4 5 6 7 8 9 10
Sweats
0 1 2 3 4 5 6 7 8 9 10
Hot Flashes
0 1 2 3 4 5 6 7 8 9 10
Sleep Disturbances
0 1 2 3 4 5 6 7 8 9 10
Fatigue
0 1 2 3 4 5 6 7 8 9 10
Vaginal Dryness
0 1 2 3 4 5 6 7 8 9 10
Depression
0 1 2 3 4 5 6 7 8 9 10
Headache
0 1 2 3 4 5 6 7 8 9 10
Irritability
0 1 2 3 4 5 6 7 8 9 10
Muscle or joint pain
0 1 2 3 4 5 6 7 8 9 10
Nervousness
0 1 2 3 4 5 6 7 8 9 10
Palpitations
0 1 2 3 4 5 6 7 8 9 10
Dizzy or Faint
0 1 2 3 4 5 6 7 8 9 10
Breast Tenderness
113
Tool for data collection - Tamil
114
115
116
117
118
ANNEXURE- 10
119
ANNEXURE- 11
Certificate of validation for kitchen weighing scale
120
ANNEXURE- 12
Certificate of validation for weighing scale
121
ANNEXURE- 13
Letters from International experts
122
123
INTRODUCTION
OBJECTIVES
REVIEW OF
LITERATURE
METHODOLOGY
RESULTS
DISCUSSION
CONCLUSION
SUMMARY
BIBLIOGRAPHY
ANNEXURES
FEEDBACK
PERCEPTION
Women perceive 2 or In experimental
more symptoms a group, 20
Nurse day persisting for the women
last 1 month
JUDGEMENT
JUDGEMENT
Soya bean may have INTERACTION
an effect in reducing
menopausal
symptoms
symptoms
ACTION Assessment of baseline
1. Preparing
ACTION the soya variables
1.
bean
Preparing
laddu for
thethe
soya Administer the Wiklund
Menopausal bean
experimental
laddu forgroup
the REACTION menopausal symptom scale
women before the intervention TRANSACTION
experimental
and rice laddugroup
for the
working in St. and
control
ricegroup
laddu for the Mutual goal
setting by Compare pre, mid
JNAHS– control
3. Administering
group the Administer 25 gram of soya
Bangalore with 3.
preparation
Administering
for a the investigator bean laddu for the experimental and post-test
selected preparation
duration of 30fordays
a and the group and 25 gram rice laddu scores of both
baseline duration of 30 days women for for the control group for 15 groups
variables- [age, participation days
duration of Administer the Wiklund
ACTION in the study.
menopause, menopausal symptom scale on
Give consent for the 15th day
marital status, participating in the .
occupation, study Continue the intervention for
type of JUDGEMENT another 15 days.
menopause, Willingness to Administer the Wiklund
In distraction
BMI, support participate in the menopausal symptom scale on
study. group, 40
system, stress the 30th day
reduction PERCEPTION children were
techniques, Menopausal symptoms selected
In control group
are bothersome and
alternative 20 women
interfere with the
systems quality of life
practice].
FEEDBACK
Figure 1: Conceptual framework based Imogene King’s Goal attainment theory

17

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A Study to assess the effectiveness of soya bean on menopausal symptoms among

women working in St. John’s National Academy of Health Sciences– Bangalore

Ms. Monica Rita Hendricks

Dissertation submitted to the

Rajiv Gandhi University of Health Science, Karnataka, Bangalore.

of the requirements for the degree of

Master of Science in Nursing

OBSTETRICS AND GYNAECOLOGICAL NURSING

Under the guidance of

Sr. Mariam O J (Sr. Celcy Mary)

Department of obstetrics and gynaecological nursing

St. John’s College of nursing

St. John’s National Academy of Health Sciences

DECLARATION BY THE CANDIDATE

Reg. No: 11NO267 Monica Rita Hendricks

Date: MSc Nursing

Place: Bangalore St. John’s College of Nursing

Date: Signature of the guide

Place: Bangalore Sr. Mariam O J (Sr. Celcy Mary)

Department of OBG Nursing

St. John’s College of Nursing

Date: Signature of the Co- Guide

Place: Bangalore Dr. Rita Mhaskar

Sr. Mariam O J (Sr. Celcy Mary) Mrs. Madonna Britto

Place: Bangalore Place: Bangalore

Declaration by the candidate

Date: Signature of the candidate

Place: Bangalore Monica Rita Hendricks

© Rajiv Gandhi University of Health Sciences, Karnataka

sustained me throughout this endeavour.

me in accomplishing this task successfully.

Sr. Mariam O J (Sr. Celcy Mary) Associate Professor, Department of Obstetrics

and Gynaecological Nursing, St. John’s College of Nursing. I express my heartfelt

suggestions in nurturing a true spirit of research. Her invaluable contributions

transformed my work and gave precision to this manuscript.

Dr. Rita Mhaskar M D, Professor, Department of Obstetrics and Gynaecologyfor

time for me with cheerfulness amidst her busy schedule.

guidance and encouragement to ensure best quality in this piece of work.

Special thanks to Prof. Mercy P. J, M. Sc. Co-ordinator, Prof. Mary Ann

Washington, for their prayers, concern, guidance, understanding andencouragement

director, Sr. Lizy Poonolil, Nursing Superintendent, for providing me the

opportunity to undertake this study.

My in depth gratitude to Mrs. Salomi Thomas, Associate Professor, Dr. Priyanka

I pay my gratitude to Mrs. Siromony Nirmala Rani, P G English, Sacred Heart

Convent HSS Villipuram for editing my manuscript.

prayers, support and encouragement.

unfailing support all through my study.

thanks to all my classmates for their timely help and support

Date: Signature of the candidate

Place: Bangalore Monica Rita Hendricks

1. HRT : Hormone Replacement Therapy

2. BMI : Body Mass Index

3. NIH : National Institute of health

4. NCCAM : National Centre for Complementary

and Alternative Medicine

5. OPD : Out Patient Department

6. RCT : Randomized controlled trial

7. CEE : Conjugated Equine estrogen

8. MPA : Medroxyprogesterone Acetate

9. MBSRQ : Multidimensional body- self relations

10. FSH : Follicle stimulating hormone

11. LH : Luteinizing hormone

12. HDL : High density lipoprotein