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Aims and objectives. (1) To evaluate the influence of local cold on severity of labour pain and (2) to identify the effect of local
cold on maternal and neonatal outcomes.
Background. Fear of labour pain results in an increase in pain and duration of labour, maternal discontent and demand for
caesarean section. Regarding maternal and foetal complications of analgesic medications, the attention to application of
nonpharmacological methods including cold therapy is increased.
Design. Randomised controlled trial.
Methods. Sixty-four pregnant women, at initiation of active phase of labour, were allocated randomly to cold therapy and
control groups (n = 64). Null parity, term pregnancy, presence of single foetus, cephalic presentation and completing
informed consent were considered as inclusion criteria. Administration of analgesic and anaesthesia, foetal distress, skin
lesions in regions of cold therapy and high-risk pregnancy provided exclusion criteria. Cold pack was applied over abdomen
and back, for 10 minutes every 30 minutes during first phase of labour. Additionally, cold pack was placed over perineum,
for 5 minutes every 15 minutes during second phase. Pain severity was assessed based on the visual analogue scale.
Results. The two groups were not significantly different considering demographic data, gestational age, foetal weight, rup-
ture of membranes and primary severity of pain. Degree of pain was lower in cold therapy group during all parts of active
phase and second stage. Duration of all phases was shorter in cold therapy group in all phases. Foetal heart rate, perineal
laceration, type of birth, application of oxytocin and APGAR score were not significantly different between two groups.
Conclusion. Labour pain is probably reduced based on gate theory using cold. Pain control by cold maybe improves labour
progression without affecting mother and foetus adversely.
Relevance to clinical practice. Local cold therapy could be included in labour pain management.
Authors: Marjan Ahmad Shirvani, MSc, Senior Lecturer, Depart- Correspondence: Jila Ganji, Senior Lecturer, Faculty of Nursing
ment of Midwifery, Mazandaran University of Medical Sciences, and Midwifery, Vesal st. Sari, Iran. Telephone: +01133367343.
Sari School of Nursing & Midwifery, Amir Mazandarani Boule- E-mail: zhila.ganji@yahoo.com
vard, Vesal St. Sari; Jila Ganji, MSc, Senior Lecturer, PhD Student
in Reproductive Health, Member of Student Research Committee,
Department of Midwifery, Mazandaran University of Medical
Sciences, Sari, Iran
fear exacerbates the pain and vice versa (Saisto et al. 2001, according to parity was 105 with CI 95%: 097–113 (The
Leeman et al. 2003, Cunningham et al. 2010). Fear and CNM Data Group 1998). In a study performed on 46
anxiety stimulate sympathetic system and increase catechol- women, 41 (911%) were trained to use cold/heat, but only
amine that results in more pain, prolonged labour and 13 (28%) had applied the method (Brown et al. 2001).
unsatisfactory experience of labour (Fuchs & Fuchs 1984, Although cold therapy is being used as a conventional
Alehagen et al. 2001, Sercekus & Okumus 2007). method for peripartum women, to our knowledge, there is
The nature of labour pain differs from other pains as it no randomised controlled trial evaluating effect of cold in
results from uterus contractions–which are painful in con- decreasing labour pain. Most studies in this field have eval-
trast to muscular physiological spasms–not from real uated the effect of cold on reducing perineal pain (Ramler
trauma, tissue damage or abnormal procedure. Various & Roberts 1986, Leventhal et al. 2011, East et al. 2012) or
aetiologies are considered to be responsible for painful stimulating acupuncture points (Waters & Raisler 2003). In
myometrium contraction including hypoxaemia, pressure the present study, we aimed to evaluate the effect of cold
on neuronal ganglions of cervix and lower parts of uterus, on severity of pain and maternal and neonatal outcomes.
distension of cervix and peritoneum covering fundus, in
addition to stretching of vagina and perineum and pressure
Methods
on pelvic floor muscles during the second phase of labour
(Leeman et al. 2003, Cunningham et al. 2010, El-Wahab
Design
& Robinson 2011). As labour progression is dependent on
distension of vagina and perineum and uterus contractions, This study was a randomised controlled trial with parallel
it is not possible to remove the pain source and methods design that was performed in two hospitals in northern Iran
should be applied for decreasing the pain. On the other between September 2011–March 2012.
hand, most pregnant women request some kind of pain
relief during labour (Fridh & Gaston-Johansson 1990,
Study subjects
Kangas-Saarela & Kangas-K€arki 1994, Goldberg et al.
1999). Nowadays, using nonpharmacological methods is Sixty-four pregnant women admitted to labour unit were
preferred as drug administration during birth is limited randomly allocated to two groups as cold therapy (n = 32)
based on maternal and foetal complications, decreased par- and control (n = 32). The head of research generated the
ticipation of mothers during labour, need for a specialist random allocation sequence by numbered cards. The groups
and financial burden (Simkin & Bolding 2004, Cunningham were matched based on the rupture of membranes and
et al. 2010). body mass index (BMI). Inclusion criteria included the
following: null parity, age of 18–35, gestational age of
37–41 weeks, single pregnancy, cephalic presentation and
Background
cervix dilatation of 3–4 cm. Patients with psychiatric disor-
It has been shown that application of severe cold–ice–exerts ders, contracted pelvic, chronic systemic disorders, dermato-
strong and transient analgesic effect; consequently, its serial logical problems in cold therapy region and complications of
application can be beneficial (Ernst & Fialka 1994). Local pregnancy such as gestational hypertension, decrease in foetal
application of cold is a nonpharmacological sensory movement, foetus growth retardation, foetal death, abnormal
intervention applied in a wide range–superficial cold to ice foetal heart rate and application of other pharmacological or
massage–on back, anus and perineum for attenuating deliv- nonpharmacological analgesic methods were excluded.
ery pain (Lieberman 1992, Simkin 1995, Simkin & Bolding
2004, Allaire 2007). Different instruments are used for this
Ethical considerations
purpose such as ice-filled glove, rolling pin and ice water–
dampened towel (Simkin & Bolding 2004). The Ethical Committee of Mazandaran University of Medi-
In a study in 210 delivery units in Britain, it was demon- cal Sciences approved the study’s protocol. The researcher
strated that cold packs were applied in 44 (21%) centres explained the study to all eligible parturient women who
for pain control during the second phase of labour (Sanders were candidates for vaginal birth, when they were admitted
et al. 2005). In 9 maternity centres in USA, only 22% of to the labour unit. Then, if they agree to participate, the
parturient women received local cold or heat; however, the researcher would provide them information form and reply
most probability of spontaneous vaginal birth was seen in to probably questions in the onset of active phase of
this group; the adjusted probability of spontaneous birth labour. They completed the informed consent form before
enrolling in the study. Participants could leave the study respectively, and repeated measurement for evaluating
whenever they want. Also, they are not required to pay for course of changes in and between two groups. The statisti-
addition cares. cal significance was considered as a p value less than 005.
Intervention Results
In cold therapy group, a trained doula, who was a midwife, Eighty-two parturient women were assessed, and after
applied a 25 9 15 cm ice bag filled with 500 gr ice covered exclusion of some women due to existence of confounder
by a towel over back, abdomen and lower parts of the variables and decline to participate, finally 64 eligible
abdomen for 10 minutes since initiation of active phase women were enrolled in two groups of cold pack and
and repeated 30 minutes later. Additionally, she applied a control consisting of 32 women in each group (Fig 1). No
15 9 10 cm cool pack filled with 200 gr ice over perineum significant difference was observed for obstetric and
during the second phase of delivery for 5 minutes every demographic characteristics between the two groups
15 minutes. The intervals were selected based on the mini- (Table 1).
mum time for initiation of cold effect, 5–10 minutes, and Pain severity comparison based on the VAS score during
its long effect (Pasero & McCaffery 1999). To control the different labour phases revealed no significant differences
supporter effect, the doula gave the same supportive cares between the two groups at the initiation of active phase
to mothers in the control group during the labour. Also, (681 19 in cold therapy group and 70 203 in the
the researcher had awarded. her about importance of simi- control group), while the differences were significant during
larity in supportive cares and checked it during the study. other phases. The pain severity was 553 134 and
A bedside midwife did routine care in both groups, such as 696 210 (p < 002) during acceleration phase,
control of foetal heart rate and uterine contractions, appli- 609 155 and 793 141 (p = 00001) through maxi-
cation of oxytocin if it was necessary and perform delivery mum of slope, 621 147 and 884 132 (p = 00001)
and episiotomy. We did not apply additional interventions in deceleration phase and 650 164 and 925 110
except for routine care for control group. Vaginal examina- (p = 00001) during second stage of birth in cold therapy
tions were performed based on cervix situation and labour and control groups, respectively. So degree of pain was sig-
progression, almost every 1 hour. nificantly lower in cold therapy group compared with con-
trol. Although pain increased during labour process in cold
therapy group, it was always less severe than the initial
Data collection
pain, while in control group, pain rose to a level more than
Obstetric and demographic information of patients was col- that of the initial phase except for acceleration phase.
lected by interview and reviewing the record files. Pain Repeated measurement test revealed a significant difference
severity was assessed by visual analogue scale (VAS). between the two groups in pain severity by time; addition-
A trained midwife asked participants of the two groups to ally, a significant interaction was found between the degree
demonstrate the severity of pain on VAS at the beginning of pain and kind of intervention. Figure 1 demonstrates
of the active phase (dilatation of 3–4 cm), acceleration sequence of change in pain severity by time between the
phase (dilatation of 5–6 cm), maximum of slope (dilatation two groups.
of 7–8 cm), deceleration (dilatation of 9–10 cm) and the Duration of first, second and third stages of labour and
second phase of labour. She recorded the data about dura- application of oxytocin were significantly shorter in cold
tion of all phases of delivery, obstetric interventions and therapy group, but no significant difference was observed
maternal, foetal and neonatal outcomes in sheets for both between the two groups considering foetal heart rate, 1st
groups. Patients’ satisfaction about labour experience was and 5th minute’s APGAR score, type of delivery and peri-
evaluated at the end of delivery by a five-point Likert ques- neal injury (Table 2).
tionnaire. In the cold therapy group, 531% and 375% of patients,
respectively, were moderately and highly satisfied about the
process of labour. On the other hand, in the control group,
Statistical analysis
most patients were unsatisfied or poorly satisfied and only
We used mean, standard deviation and frequency for 1 woman (31%) was highly satisfied. The difference in sat-
description of variables, chi-squared test and t-test for isfaction rate between the groups was significant
comparison of qualitative and quantitative variables, (p = 00001) (Fig. 2).
Table 1 The personal and obstetric characteristics of cold pack and control groups
Age (year) M SD *
2853 541 2856 54 NS†
BMI (Kg/m2) M SD 2655 771 2512 387 NS
Education
Illiterate 1 (500%) 1 (500%)
Primary 8 (533%) 7 (467%) NS
High school 11 (500%) 11 (500%)
University 12 (480%) 13 (520%)
Gestational age (week) M SD 3909 085 3903 086 NS
Neonatal weight (gr) M SD 33875 24724 33906 23740 NS
PROM‡
Yes 15 (556%) 12 (444%) NS
No 17 (459%) 20 (541%)
Oxytocin application
Yes 16 (485%) 17 (515%) NS
No 16 (516%) 15 (488%)
Table 2 The comparison of delivery outcomes between cold pack and control groups
pe
e
se
ag
tio
tio
slo
On
st
While pain significantly increased during the second phase
ra
ra
of
nd
le
la
ce
ce
co
um
De
Ac
in the cold therapy group and was even milder than in the
Labor phases
initiation of active phase.
Various mechanisms are thought to be involved in the Figure 2 The changes in labour pain in cold pack and control
analgesic effects of cold therapy, including change in nerve group.
conduction velocity, attenuation or block of pain conduction
to central nervous system via gate control theory, mind devi- that result in prolonged labour (Sercekus & Okumus 2007,
ation from pain, improvement of energy flow in acupuncture El-Wahab & Robinson 2011). It seems that effective uterus
points and decreased muscle stretch, which all result in contractions produced by cold therapy persisted after birth,
increase in pain perception threshold (Ernst & Fialka 1994, as the third stage was also significantly shorter in the
The CNM Data Group 1998, Simkin & Bolding 2004). experiment group. Curkovic and Vitulic reported cold
Gate control theory describes change of pain perception in application increases pain threshold after 10–30 minutes
brain by other stimulant competitive sensory signals (Wall (Curkovic & Vitulic 1993). Pasero et al. reported higher
1978). Also, Totonchi et al. reported a reduction in anxiety and longer efficacy of cold therapy in pain reduction com-
by cold therapy. Then it seems that decrease in catechol- pared with heat application (Pasero & McCaffery 1999).
amine and increase in endorphin are other mechanisms of Consequently, the effect of cold may last up to the third
pain management via cold therapy (Tootoonchi et al. 1999). stage of labour after eliminating the source. Decrease in
Furthermore, duration of all stages was shorter in cold duration of birth contributes to lower maternal fatigue,
therapy group. Severe pain increases fear and anxiety, so decreased postpartum bleeding and prevention of unneces-
stimulates sympathetic system and releases catecholamine sary interventions. It seems that reduction in pain and birth
duration is independent of oxytocin consumption and rup- phase of labour, in addition to perineum in the second
ture of membranes, as they were similar in both groups. phase, causes significant reduction in labour pain. Further-
Alehagen et al. showed that the amount of pain relief influ- more, based on the results, it probably has a benefit effect
ences the correlation between fear and duration of the sec- on labour phases without adverse effect on mother and foe-
ond phase of labour (Alehagen et al. 2001). As no other tal outcomes. More investigation into blind placebo group
pain-relieving method was applied and a doula was present is suggested. For above reasons, cold therapy is said to be
in control group, to eliminate the effect of supporter factor, associated with higher satisfaction of mother.
it seems that the cold therapy was the major effective factor.
Evaluating maternal and foetal outcomes considering foe-
Relevance to clinical practice
tal heart rate, APGAR score, instrumental delivery and per-
ineal laceration demonstrated no adverse effect due to use Pain is an inevitable part of labour. Consideration to man-
of cold pack. As heat prevents perineal laceration by agement of labour pain is important because it can affect
stretching the perineum, it is expected that cold acts rever- the progress of labour and mother’s experience of birth. It
sely (Sanders et al. 2005); although the rate of perineal lac- seems that application of cold therapy is a safe, simple and
eration was higher in cold therapy group, it was not available method with no need of experts who significantly
significantly different from the control group. However, relieve labour pain.
certain conclusions about cold effect on perineal laceration
are not possible because routine episiotomy was performed
Disclosure
in most of the patients in both groups. It seems that a sig-
nificant decrease in duration of oxytocin application is due The authors have confirmed that all authors meet the
to more effective uterine contractions. ICMJE criteria for authorship credit (www.icmje.org/
Maternal satisfactory rate was higher in cold therapy ethical_1author.html), as follows: (1) substantial contribu-
group, considering the shorter duration of labour and lesser tions to conception and design of, or acquisition of data or
pain. In a study performed by Brown et al., none of the analysis and interpretation of data, (2) drafting the article
patients assessed topical cold/heat application ineffective or revising it critically for important intellectual content,
(Brown et al. 2001). Nonpharmacological methods includ- and (3) final approval of the version to be published.
ing cold therapy increased maternal satisfaction by inducing
control and empowerment feelings (Mackey 1995, Walden-
Conflict of Interest
strom et al. 1996, Brown et al. 2001).
Only 4 women declined to participate in this study. The authors have no conflict of interests to disclose. The
Women’s interest to the subject of labour pain control and registration number in IRCT (www.irct.ir) was 20110827
researcher’s explanations at the time of admission about the 7422N1.
process of study may be the reasons of this low decline. Of
course, it was a limitation of the study that no placebo
Acknowledgement
group was compared with the experiment group.
This study was approved by Research Deputy of Mazanda-
ran University of Medical Sciences (project no. H89-
Conclusion
26).The authors would like to acknowledge this respectable
According to this study, application of local cold to the duty for financial support. Also we thank Dr. Khalilian for
back, abdomen and lower part of abdomen in the first statistical advice.
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