Accepted Manuscript

Title: Application of cabbage leaves compared to gel packs for

mothers with breast engorgement: Randomized controlled trial

Authors: Wong Boh Boi, Chan Yiong Huak, Mabel Leow, Lu

Yi, Chong Yap Seng, Koh Serena Siew Lin, He Hong-Gu

PII: S0020-7489(17)30193-1
DOI: http://dx.doi.org/10.1016/j.ijnurstu.2017.08.014
Reference: NS 3005

To appear in:

Received date: 3-1-2017

Revised date: 6-7-2017
Accepted date: 24-8-2017

Please cite this article as: Wong, Boh Boi, Chan, Yiong Huak, Leow,
Mabel, Lu, Yi, Chong, Yap Seng, Koh, Serena Siew Lin, He, Hong-Gu,
Application of cabbage leaves compared to gel packs for mothers with breast
engorgement: Randomized controlled trial.International Journal of Nursing Studies
http://dx.doi.org/10.1016/j.ijnurstu.2017.08.014

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Descriptive title: Application of cabbage leaves compared to gel packs for mothers with breast

engorgement: Randomized controlled trial

Running head: Mothers with breast engorgement

WONG Boh Boi, PhD, RN, RM

Lactation Consultant, Thomson Medical Centre, Singapore
PhD Graduate, Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine,
National University of Singapore, Singapore
Email: bbwong@thomsonmedical.com

CHAN Yiong Huak, PhD

Head, Senior Biostatistician, Biostatistics Unit, National University of Singapore, Singapore
Email: medcyh@nus.edu.sg

Mabel LEOW, PhD, RN

Research Scientist, Biomechanics Laboratory, Singapore General Hospital, Singapore
Email: mabelleowqihe@yahoo.com

LU Yi, PhD
Research Fellow, Department of Paediatrics, National University of Singapore, Singapore
Email: paely@nus.edu.sg

CHONG Yap Seng, MD

Senior Consultant, Department of Obstetrics and Gynecology, National University Hospital;
Associate Professor, Yong Loo Lin School of Medicine, National University of Singapore,
Singapore
E-mail: obgcys@nus.edu.sg

1
Serena KOH Siew Lin, PhD, RN, RM
Associate Professor, Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine,
National University of Singapore, Singapore
Email: nursere@nus.edu.sg

HE Hong-Gu, PhD, RN, MD

Associate Professor, Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine,
National University of Singapore, Singapore
Email: nurhhg@nus.edu.sg

Corresponding author:
A/Prof HE Hong-Gu, PhD, RN, MD
Associate Professor,
Alice Lee Centre for Nursing Studies
Yong Loo Lin School of Medicine
National University of Singapore
Level 2, Clinical Research Centre
Bock MD11, 10 Medical Drive, Singapore 117597
Tel: (65) 6516 7449; Fax: (65) 6776 7135;
Email: nurhhg@nus.edu.sg

ABSTRACT

Background: The effects of cold cabbage leaves and cold gel packs on breast engorgement

management have been inconclusive. No studies have compared the effects of these methods on

breast engorgement using a rigorous design.

Objectives: To examine the effectiveness of cold cabbage leaves and cold gel packs application

on pain, hardness, and temperature due to breast engorgement, the duration of breastfeeding and

satisfaction.

2
Design: A randomised controlled three-group pre-test and repeated post-test study.

Setting: A private maternal and children’s hospital in Singapore.

Participants: Mothers (n = 227) with breast engorgement within 14 days after delivery.

Methods: The mothers were randomly assigned into either cold cabbage leaves, cold gel packs,

or the control group. Pain, hardness of breasts, and body temperature were measured before

treatment. Two sets of post-test assessments were conducted at 30 minutes, 1 hour, and 2 hours

after the first and second application. The duration of breastfeeding was measured up to 6

months. IBM SPSS 23.0 was used to analyse the data.

Results: Mothers in the cabbage leaves and gel packs groups had significant reductions in pain at

all post-intervention time points compared to the control group, starting from 30 minutes after

the first application of cabbage leaves (mean difference = -0.38, p = 0.016) or gel packs (mean

difference = -0.39, p = 0.013). When compared to the control group, mothers in the cabbage

leaves group had significant reductions in the hardness of breasts at all post-intervention time

points, and mothers in the gel packs group had significant reductions in the hardness of breasts at

two time points (1 hour and 2 hours after the first and second application, respectively). Mothers

in the cabbage leaves group had significant reductions in pain (mean difference = -0.53, p =

0.005) and hardness of breasts (mean difference = -0.35, p = 0.003) at 2 hours after the second

application compared to those in the gel packs group. Both interventions had no impact on body

temperature. There was no significant difference in the durations of breastfeeding for mothers

among the three groups at 3-month and 6-month follow-up. More mothers were very

satisfied/satisfied with the breast engorgement care provided in the cabbage leaves group

compared to the other groups.

Conclusion: While cold cabbage leaves and cold gel packs can relieve pain and hardness in

3
breast engorgement, the former had better effect, which can be recommended to postnatal

mothers to manage breast engorgement.

Keywords: Breast engorgement, cabbage leaves, gel packs, mothers, postnatal, randomized

controlled trial

(Word count: Abstract: 400; Main text: 4,892)

INTRODUCTION

Breast milk is considered the most desirable food for babies. There has been extensive research

in various countries providing evidence that breastfeeding has short-term and long-term benefits

to both mothers and infants. Most new mothers who breastfeed find it a deeply satisfying

experience, both physically and emotionally (Lawrence and Pane, 2011). The World Health

Organisation (WHO, 2002) has emphasised the importance of breastfeeding for a duration of

greater than six months, and most countries, including Singapore, promote exclusive

breastfeeding. In Singapore, 50% of the mothers breastfeed their infants exclusively when they

are discharged from the hospital (Chua and Win, 2013).

Breast engorgement is a common physiological problem for lactating mothers, which can

be due to the rate of secretion that exceeds the rate of the ejection of milk and/or poor/shallow

latching from the baby. The reported incidence of breast engorgement varied among studies,

ranging from 20% to 77% (Spitz et al., 1998; Walker, 2000). Based on an internal survey at the

private hospital where the current study was conducted, the incidence was about 20%.

There are numerous consequences of breast engorgement: painful swelling breasts

associated with sudden increase in milk volume, lymphatic and vascular congestion, and
4
interstitial oedema during the first congestion (Lawrence and Pane, 2007; Lawrence and

Lawrence, 2011). Studies have reported that poor management of breast engorgement leads to

the failure of milk production during the early postpartum period, resulting in an early cessation

of breastfeeding (Lawrence and Pane, 2007; Snowden et al., 2001; Walker, 2000). The major

reason for an early cessation of breastfeeding is due to the pain caused by breast engorgement

(Foo et al., 2005). If breast engorgement is not managed effectively, it can lead to mastitis and

breast abscess (Olds et al., 2000).

The main aim of the management of breast engorgement is to successfully establish and

maintain the flow of breast milk and empty the breast milk effectively via the baby or expression

to prevent engorgement (Lawrence and Pane, 2007). Current approaches involve a combination

of pharmacotherapy (Snowden et al., 2001) such as pain medications and non-pharmacological

management such as direct massage to the areas with blocked ducts (Snowden et al., 2001;

Walker, 2000), cold cabbage leaves (e.g. Arora et al., 2008; Nikodem et al., 1993; Roberts et al.,

1995), cold gel packs (Roberts, 1995), cabbage leaves extract (Roberts et al., 1995), gua-sha as a

form of Chinese massage (Chiu et al., 2010), acupuncture (Kvist et al., 2007), therapeutic

ultrasound (Mclachlan et al., 1993), and breast binding (Swift and Jankle, 2003).

Non-pharmacological treatments for breast engorgement are becoming increasingly

popular. The use of cabbage leaves is a popular non-pharmacological method used in managing

breast engorgement and it can reduce the discomfort, tenderness, and swelling of breasts (Arora

et al., 2008; Roberts et al., 1995; Robson, 1990). The cabbage leaves contain enzymes such as

sinigrin and rapine (Joy, 2013) and have proven to be a good source of antioxidants (Nilnakara et

al., 2009). The sulfur compound in cabbage leaves has antiseptic, disinfectant, anti-bacterial, and

anti-inflammatory properties (Hatfield, 2004), which will support their use to relieve pain and

5
swelling. The temperature of cabbage leaves has an impact on its effectiveness (Rosier, 1988). In

the study hospital, non-pharmacological methods of massage, cold cabbages, and cold gel packs

were used to treat mothers with breast engorgement. A systematic review was conducted on the

effectiveness of cabbage leaf application on pain and hardness in breast engorgement and its

effect on the duration of breastfeeding (Wong et al., 2012). The review found that cabbage leaves

can potentially help to reduce the pain and hardness of engorged breasts and increase the

duration of breastfeeding, but the results were inconclusive. Nikodem et al. (1993) reported that

when compared to mothers in the control group, 18% more mothers who received the cabbage

leaf intervention were exclusively breastfeeding at six weeks postpartum. From the literature,

only one study has been conducted to compare the effectiveness between gel packs and cabbage

leaves (Roberts, 1995). Roberts’ (1995) study showed a reduction in pain with the breast

engorgement post-intervention with both gel packs and cabbage leaves, but there was no

significant difference in pain scores between the two groups.

Although a few studies have found that the cabbage leaf treatment and cold gel packs can

potentially reduce symptoms caused by breast engorgement, the findings from these studies were

inconclusive. Furthermore, a review of the literature identified gaps such as a lack of control

group used in the design, small sample sizes, a lack of blinding technique, a lack of follow-ups,

and inconsistency in the duration of the application of cold cabbage leaves and cold gel packs.

Hence, our study aimed to examine the effectiveness of cold cabbage leaves and cold gel packs

in improving mothers’ outcomes of pain, hardness of breasts, temperature, duration of

breastfeeding, and satisfaction using a randomised controlled trial. The hypotheses were:

(1) When compared with those in the control group, mothers using cold cabbage leaves or cold

gel packs will report lower levels of pain, hardness of breasts, and body temperatures with

6
 statistically significant differences over time in the first and second hour after the two

applications, as well as at each post-test time point;

(2) When compared with those in the cold gel packs group, mothers receiving cold cabbage

leaves application will report lowers level of pain, hardness of breasts, and body

temperatures with statistically significant differences at each post-test time point.

(3) When compared with those in the control group, mothers in the two treatment groups will

have longer durations of breastfeeding at 3-month and 6-month follow-ups with statistically

significant differences.

(4) When compared with those in the control group, more mothers will be satisfied with the

treatment of breast engorgement in the two treatment groups with statistically significant

differences.

METHODS

Study design

A randomised controlled three-group pre-test and repeated post-test study design was adopted.

Mothers were randomly assigned into intervention group 1 (cold cabbage leaves application plus

routine care), intervention group 2 (cold gel packs application plus routine care), or the control

group (routine care only).

Setting and sampling

Mothers with breast engorgement were recruited on their day of discharge from a private

maternal and children’s hospital, which has an average of 768 deliveries per month, in

Singapore. No limitations were imposed on the parities or gravity statuses of the subjects. The

inclusion criteria for the participants were mothers who were: (1) 21 years old and above; (2)

7
breastfeeding and developed breast engorgement within 14 days postpartum; (3) able to read,

understand, or speak English; (4) fulfilled 5 out of 10 criteria using the Infant Breastfeeding

Assessment Tool; and (5) demonstrated at least a score of 5 out of 10 using a breastfeeding

assessment tool. The exclusion criteria were mothers who: (1) had mental disorders identified

from their medical records that would interfere with their ability to participate in the study; (2)

were taking lactation suppressants; (3) did not breastfeed their children; and/or (4) had medical

conditions that caused pain or fever (e.g. wound infection, breast infection such as mastitis,

upper respiratory tract infection, or urinary tract infection) as identified from their medical

records.

The primary unit of analysis is the differences in the outcomes of pain, hardness, and

temperature across the three groups. Postulating a medium Cohen’s effect size of 0.5 between

any treatment group and the control group, the required sample for each group was 64 to

achieve 80% power at a 5% significance level (two-sided) (Cohen, 1992). We recruited 76

patients in each group after accounting for a 20% drop-out rate. The interviews for process

evaluation were conducted on 21 mothers (7 mothers from each group). The results were

reported in the thesis by Wong (2016).

Randomisation

A block randomisation of size 6 generated randomly by a biostatistician was used to assign the

eligible mothers who consented to participate via sequentially numbered sealed opaque

envelopes into the following groups: intervention group 1 (cold cabbage leaves), intervention

group 2 (cold gel packs), or the control group. Due to the nature of the intervention, blinding the

research nurses who helped with the data collection from the allocation of the treatment was not

possible when performing pain, hardness, and temperature readings in the five-hour follow-up

8
data collection. However, the single-blinded technique was used on the nurse when the nurse

called the participants at the 3rd month and 6th month follow-ups regarding the durations of

breastfeeding and factors for stopping breastfeeding.

Intervention

Control group. Mothers in the control group received routine care provided by a lactation

consultant or a lactation advisor in the hospital. Education was provided during antenatal

classes, daily in-house postnatal teaching classes, during rounds conducted by lactation

consultants, and in available brochures in the hospital. Mothers in the control group were

informed that they were not supposed to use any other additional strategies to manage breast

engorgement until the end of the evaluation. All mothers agreed to adhere to the study protocol

prior to their consent for the study.

Cold cabbage leaves. Mothers in this group received cold cabbage leaves on top of the

routine care. They were instructed to use cold cabbage leaves on both breasts. The cabbage

leaves were from common green cabbages (Brassica oleracea). The nurse washed her hands

before preparing the cabbage leaves for use. The hard stems of the cabbage leaves were

removed. The cabbage leaves were rinsed in cold water and chilled in a zip-lock freezer bag in

the freezer for 15 minutes or in the fridge for 1 hour before application. There were two sessions

of application. For each session, three big leaves were applied on top of each other to cover the

entirety of each breast for two hours. There was half an hour break before the second session of

application.

Cold gel packs. Mothers in this group received cold gel packs on top of the routine care.

They were instructed to use cold gel packs on both breasts. Philips AVENT thermal gel pads

were distributed to all participants in this group. The gel packs in zip-locked bags were chilled in

9
the freezer for 15 minutes or in the fridge for 1 hour before application. There were two sessions

of application. For each session, one gel pack was applied on one breast for two hours. There

was half an hour break before the second session of application.

Outcomes and measurement

The participants’ sociodemographic data (age, gender, ethnicity, and education) and clinical

data (date of delivery, mode of delivery and data on type, and amount and frequency of

medications used after delivery) were obtained after receiving consent from the participants.

The outcomes measured included primary outcome of pain intensity, and secondary

outcomes of hardness of breasts, body temperature, duration of breastfeeding, and satisfaction

with breast care. Data were collected by research nurses who were trained by the main

researcher. The following instruments were used to measure the different outcomes:

- The Numerical Rating Scale (pain) was used to measure pain intensity. Mothers were asked

to assess their pain from 0 to 10 on a horizontal line, with 0 meaning ‘no pain’ and 10

meaning ‘the worst possible pain’ (Arora et al., 2008). In this study, a pain score of 4 to 6

indicated moderate pain and 7 to 10 indicated severe pain (McCaffery and Beebe, 1993).

- The Breast Engorgement Assessment Scale was used to assess the hardness of the breast.

This scale was developed based on the simple descriptive scale used by Nikodem et al.

(1993) and Roser (1966), and has been routinely used in the participating hospital to assess

breast engorgement. Breast engorgement was graded from 1 to 6. Grade 1 means that the

breasts are soft and milk flows freely whereas grade 6 means that the breasts are very hard

and painful and no milk flows. A score of 4 and above is classed as breast engorgement.

- An oral thermometer was used to measure each mother’s body temperature. Fever was

defined as a temperature measurement of above 38 degrees Celsius. This method was

10
 supported by other studies (Lawrence and Lawrence, 2005; Riordan et al., 2005) and also

recommended by the International Board of Lactation Consultant Examiners.

- The duration of breastfeeding was measured at 3 and 6 months after delivery.

- A 6-point Ordinal Descriptive Satisfaction Scale was used to assess mothers’ self-reported

levels of satisfaction with breast engorgement care. This was used by previous studies to

measure participants’ satisfaction with treatment (He et al., 2015; Shorey et al., 2015b).

Data collection procedure

The study was conducted from March 2013 to April 2014. For patients who were in the hospital

throughout the study period, trained research nurses helped to obtain follow-up measurements

from the patients. However, 27 mothers (out of 227, 12%) were unable to stay in the hospital

throughout the study duration. Among these mothers, a balanced distribution of 8, 9 and 10

mothers were from intervention group 1 (cold cabbage leaves), intervention group 2 (cold gel

packs), and the control group, respectively. Hence, the main researcher or research nurses

trained the participants to measure the outcomes themselves. They were taught to assess their

breasts before and after the intervention, using the Breast Engorgement Assessment Scale for

the hardness of engorged breasts, using the Numerical Rating Scale-pain for pain, and

measuring their temperature with an oral thermometer provided by the hospital. Mothers’

satisfaction was obtained based on their subjective satisfaction. Data for pain, hardness, and

temperature were collected at seven time points: the baseline, 30-minute, 1-hour, and 2-hour

post first application, and 30-minute, 1-hour, and 2-hour post second application. Satisfaction

was obtained at 2-hour post second application. The mothers who were unable to stay in the

hospital throughout the study duration sent the data back to the main researcher via the mobile

phone application ‘WhatsApp’ or by mail once completed. At 3-months and 6-months, phone

11
calls were made by the research nurses, who were unaware of the allocation of the treatment

groups, to ask if the mothers were still breastfeeding and if not, when they stopped

breastfeeding.

Ethical considerations

Prior to conducting the study, ethics approval was obtained from the participating hospital

(Document ID: 0636-001) in February 2013 and endorsed by the university. The purpose and

content of the study were explained to the participants. They were informed that their

participation was voluntary and that they could withdraw from the study at any time without any

negative impact on the care they were entitled to. Confidentiality of their identities and research

data was also ensured.

Data analysis

All analyses were performed using IBM SPSS Statistics for Windows 23.0 (IBM Corp., Armonk,

NY) with the statistical significance set at p<0.05. Descriptive statistics of mean (SD) were used

for reporting normally-distributed numerical variables, otherwise the median (interquartile range)

was presented, and n(%) was used to describe categorical variables. For numerical variables

satisfying the normality and homogeneity assumptions (age and baseline outcomes), one-way

analysis of variance was used to compare the three treatment groups. The differences of

categorical variables (sociodemographic and clinical variables, duration of breastfeeding, and

satisfaction) among the three groups were assessed using Chi-square test or Fisher’s exact test.

Repeated measures analysis of covariance using a mixed model was performed to compare the

three outcomes over the periods across the three groups, adjusting for baseline values, age,

ethnicity, current birth, gestational age (days), education level, and medication. Comparisons of

12
the three outcomes among the three groups at each time point were compared using univariate

analysis of covariance (General Linear Model), adjusting for baseline values, age, ethnicity,

current birth, gestational age (days), education level, and medication. Pairwise comparisons were

Bonferroni adjusted. Using General Linear Model, the regression slopes were utilised to show

the rate of change per 10 minutes for pain, hardness, and temperature by groups and also to

compare the rate of change across groups.

RESULTS

Among the 240 mothers approached, 228 were recruited in the study. All 228 mothers

completed the baseline data collection, but one mother from the cold gel pack group dropped

out before the commencement of the intervention as her baby had severe jaundice. Therefore, a

total of 227 were eligible for final data analysis. Five out of these 227 mothers were

uncontactable at the 3-month follow-up, and two mothers out of 164 who were still

breastfeeding at the 3-month follow-up were not contactable at the 6-month follow-up. Figure 1

represents the CONSORT diagram of the study.

Figure 1 here
Comparison of sociodemographic and clinical variables of the participants as well as

baseline outcomes among the three groups

There was no significant difference in the sociodemographic and clinical characteristics of age,

ethnicity, education, total family income, gestational age, whether the baby roomed-in with the

mother, exclusive breastfeeding, massage, or pain relief medication (Table 1). Table 1 also

shows that there were no significant differences in the baseline outcomes of pain, hardness of

breasts, or body temperature among the three groups.

Table 1 here

13
Comparison of outcomes (pain, hardness of breasts, and body temperature) among the

three groups over time and at each post-intervention time point

Hypotheses 1 and 2 were partially supported. The repeated measures ANCOVA showed that

there were significant time effects for outcomes of pain, hardness of breasts, and body

temperature at all time points, significant group*time interaction effect for pain and hardness of

breasts, but no significant group effect for all outcomes over time for the first and second

application (Table 2 and Supplementary Figure 1).

Table 2 here
However, the univariate ANCOVA for comparison of pain (Table 3) and hardness of

breasts (Table 4) at each post-test time point showed significant differences among the three

groups. As shown in Table 3 and Supplementary Figure 1, mothers who received the cabbage

leaves and gel packs interventions consistently had significantly lower pain scores compared to

the routine group at all time points. Mothers who received the cabbage leaves intervention had

significantly lower pain scores compared to those in the cold gel packs groups at 2 hours after

the second application (mean difference=0.53, 95% CI: 0.16-0.9, p=0.005).

Table 3 here
As shown in Table 4 and Supplementary Figure 1, mothers who received the cold cabbage

leaves intervention had significantly lower hardness scores compared to those in the routine

group at all time points, while mothers who received the cold gel packs intervention had

significantly lower hardness scores compared to those in the routine group at two time points: 1

hour after the first application and 2 hours after the second application. Moreover, mothers who

received the cabbage leaves intervention had significantly lower hardness scores compared to

those in the cold gel packs groups at 2 hours after the second application (mean difference=0.35,

95% CI ranged from 0.12 to 0.58, p=0.003).

14
 Table 4 here
Supplementary Table 1 and Supplementary Figure 1 show that there were no significant

differences in body temperature among the three study groups at all post-intervention time

points. Cold cabbage leaves and cold gel packs had no impact on body temperature.

Using GLM, the regression slopes (Supplementary Table 2) show the rate of change per 10

minutes increment for pain, hardness of breasts, and body temperature by groups, and the rates of

change across groups were also compared. There were significant reductions in pain, hardness,

and temperature per 10 minutes increment for all three groups, except for temperature in the cold

cabbage leaves group (rate of change per 10 minutes increment=0.0018, 95% CI ranged from

0.002 to 0.006, p=0.354). Pairwise comparisons showed that mothers in the cold cabbage leaves

group had significant reductions in pain (p=0.006 for cold cabbage leaves and cold gel packs

groups comparison, p<0.001 for cold cabbage leaves and routine groups comparison), hardness

(p<0.001 for both comparisons), and temperature (p=0.044 for cold cabbage leaves and cold gel

packs groups comparison, p=0.041 for cold cabbage leaves and routine groups comparison) in

the rate of change per 10 minutes increment. Mothers in the cold gel packs group had significant

reductions in pain as measured by the rate of change per 10 minutes increment (p=0.006)

compared with those in the routine group. These results confirmed the significant time effect for

all three outcomes for all three groups (Table 2), and cold cabbage leaves performed better in

reducing pain, hardness, and temperature than the cold gel packs and routine groups. Cold gel

packs performed better only in reducing pain than the routine group.

Comparison of the duration of breastfeeding among the three groups at 3-month and 6-

month follow-ups

15
A follow-up was carried out at 3 months to 222 participants (5 participants were uncontactable).

The actual durations of breastfeeding for the three groups are shown in Supplementary Table 3.

Among all mothers who answered the phone, about 25% of the mothers stopped breastfeeding in

the first 3 months (n=58, 26%) and between 3 to 6 months (n=41, 25%) postpartum. Chi-square

tests showed that there were no significant differences in the durations of breastfeeding among

the three groups at 3-months (χ²=1.7, p=0.95) and 6-months follow-up (χ²=5.3, p=0.51).

Hypothesis 3 was rejected.

Comparison of satisfaction with breast engorgement care among the three groups

Satisfaction levels were divided into three groups for comparison: ‘slightly satisfied and below’,

‘satisfied’, and ‘very satisfied’. The Chi-square test showed that there was a significant

difference in the satisfaction levels among the three groups (χ2=24.85, p<0.001). Mothers in the

cold cabbage leaves group were the most satisfied with their breast engorgement care, with the

majority being very satisfied (n=11, 14.5%) or satisfied (n=64, 84.2%), followed by the cold gel

packs group, with 8 (10.7%) being very satisfied and 53 (70.7%) being satisfied. For the routine

group, 13 participants (17.3%) were very satisfied and 40 (53.3%) were satisfied. Hypothesis 4

was supported.

DISCUSSION

This is the first study that used a rigorous design to compare the effectiveness of cold cabbage

leaves and cold gels packs for mothers with breast engorgement, with clear descriptions of the

duration of application and six post-intervention follow-ups. The majority of our participants

were over 30 years old (mean 32.9 years), Chinese, with Bachelor degree or higher education

levels, and with total family monthly incomes of over S$5,000. The sample was a representation

of the participating hospital’s population. Other local studies have reported similar

16
characteristics, which found that mothers who participated in their studies were generally older

and had higher education levels and family incomes (Ong et al. 2013; Shorey et al., 2015a). The

majority of mothers had full term delivery, and only 41% of the mothers followed exclusive

breastfeeding, which is lower than the statistics reported by Chua and Win (2013).

Our study found that cabbage leaves reduced mothers’ pain and hardness in their breasts

across the six time points compared with the routine group. Cold gel packs reduced mothers’

pain at all six time points and hardness at 1 hour after the first application and 2 hours after the

second application. However, when compared between the cold cabbage leaves and gel packs

groups, mothers who applied cabbage leaves reported lower pain and hardness only at 2 hours

post second application. In addition, mothers who received the cold cabbage leaves intervention

were also the most satisfied compared with those who received cold gel packs or routine care.

This suggested that cabbage leaves were the most effective in relieving symptoms of breast

engorgement, and resulted in the highest satisfaction. Similar effects of using cabbage leaves in

reducing pain have been reported by previous studies (Arora et al., 2008; Nikodem et al., 1993;

Robert et al., 1995). There was only one study in the literature that compared the effects of cold

cabbage leaves and cold gel packs in reducing pain, and no difference was reported (Roberts,

1995).

The greater effectiveness of cabbage leaves could be attributed to it containing enzymes

such as sinigrin and rapine (Joy, 2013) and the sulphur compound (Hatfield, 2004), which could

have had an anti-inflammatory effect on the breasts, resulting in the reduction of swelling,

hardness, and pain. Silicone gel does not contain these enzymes and inorganic compounds;

hence, it does not have any anti-inflammatory properties to reduce the hardness of the breasts.

The effectiveness of the cold gel packs in reducing pain can be attributed to it being chilled,

17
which activates the fibres responsible for providing intra-mammary pressure that causes milk

ejection (Findlay, 1996) and leads to reduced oedema and enhanced lymphatic drainage (Boyce,

2009). In addition, the flexibility of the cabbage leaves that enabled the leaves to mould to the

shape of the mothers’ breasts and wrapped their breasts completely over time could have also

enhanced its effectiveness. The silicone gel packs were wrapped in plastic that was not as

flexible as cabbage leaves. Hence, they could not accommodate different breast sizes and did

not ‘fit’ or mould around the breasts. As a result, silicone gel packs were not as fitting as

cabbage leaves.

There was no significant difference in body temperature for all groups, and no mother had

a fever. This could be the result of excluding mothers with any kind of infections, including

mastitis. This result also suggested that breast engorgement itself has no major influence on

mothers’ body temperatures.

There was no significant impact from the cabbage leaves or gel pack interventions on the

durations of breastfeeding at the 3-month and 6-month follow-ups. This finding was inconsistent

with a previous finding, which was reported by Nikodem et al. (1993), that fewer mothers had

stopped breastfeeding prior to eight days (8.88% versus 24%, p=0.09) and that the overall

duration of breastfeeding was longer in the intervention group (36 days versus 30 days, p=0.04).

The finding from this study may suggest that there was no relationship between pain and

hardness on the duration of breastfeeding. Hence, the duration of breastfeeding could be

associated with extrinsic factors such as mother-related problems (low milk supply, sore nipple,

or mother being too tired) and having to work (Wong, 2016) rather than intrinsic factors such as

pain and hardness.

Limitations of the study

18
Although the use of the double-blinded technique would have been ideal for a randomized

controlled trial, this was not possible in this study due to the nature of the interventions. The

researchers who conducted the interventions and data collection for post-intervention readings of

pain, hardness, and temperature, as well as the patients, were not blinded. The participants were

aware of the interventions they received. About 12% of the participants were discharged from

the hospital during the administration of the interventions. These participants who received the

interventions (cabbage leaves or gel packs) had to apply the interventions themselves after

discharge and self-report the outcomes. There was a possibility that some participants might not

have fully adhered to the study regimens and also might not have measured the outcomes

carefully. However, they had agreed to adhere to treatment regime, and had demonstrated their

ability to measure the outcomes according to the protocol before their discharge from the

hospital, with proper instructions provided. After receiving the hard copy of data, which were all

complete, the research nurse called them and all mothers assured her that they followed the

instructions strictly for intervention and outcome assessments as it was a research study and they

wanted the result to be truthful. Moreover, further data analyses showed that there were no any

statistical significant differences between groups (27 mothers who went home and 200 mothers

who stayed in the hospital) for all socio-demographic characteristics and all outcomes (pain,

hardness, temperature) at all time points, which indicated that this subgroup of mothers did not

affect the final results.

Implications for clinical practice

Both cabbage leaves and gel packs can be recommended for the treatment of breast

engorgement. However, cabbage leaves should be more highly recommended as it can reduce

both pain and hardness at all time points while gel packs can only relieve pain at all time points.

19
It is important to pay attention to hygiene when preparing the cabbage leaves for use. It is

recommended that cabbage leaves are rinsed with water before use. Hand-washing and wearing

plastic disposable gloves are mandatory when preparing and cutting the cabbage leaves. The

board and knife used to cut the cabbage leaves should be reserved solely for this purpose

(Wong, 2016, p.54, 179).

Recommendations for future studies

The study should be repeated in a public hospital setting, which may include participants with

more diverse educational backgrounds and family incomes. The use of cold cabbage leaves and

cold gel packs did not result in longer durations of breastfeeding through the reduction of the

pain and hardness. Future studies can look into factors that can help to increase the duration of

breastfeeding. Given the apparent effectiveness of the cabbage leaves treatment, which is

generalizable, it is also recommended that further basic science studies should be carried out to

determine whether there are any chemicals or enzymes present in cabbage leaves that result in

its greater effectiveness.

CONCLUSIONS

Cold cabbage leaves helped to relieve pain and hardness in breast engorgement at all post-

intervention time points while cold gel packs only helped to relief pain at all post-intervention

time points. Mothers who received the cold cabbage leaves intervention reported to be most

satisfied with the treatment, followed by those who received the cold gel packs intervention.

There was no difference in the durations of breastfeeding among the three groups. While both

cold cabbage leaves and cold gel packs can be used for mothers to manage their engorged breasts,

cold cabbage leaves are more highly recommended.

20
AUTHOR CONTRIBUTIONS
Study Design: WBB, HHG, SKSL, CYS;
Data Collection and Analysis: WBB, CYH, LY, HHG;
Manuscript Preparation: WBB, HHG, ML, CYH, LY, SKSL, CYS

FUNDING STATEMENT
This study received no specific grant from any funding agency in the public, commercial, or not-
for-profit sectors.

DECLARATION OF CONFLICT OF INTEREST

The author(s) declared no potential conflicts of interest with respect to the research, authorship,
and/or publication of this article.

Contribution of the Paper

What is already known about the topic?

- Breast engorgement is a common physiological problem for lactating mothers that may cause

breast swelling, pain, fever, and eventually a cease in breastfeeding in the early postpartum

period.

- The effects of cold cabbage leaves and cold gel packs on the management of breast

engorgement have been inconclusive in literature.

What this paper adds:

- Cold cabbage leaves and cold gel packs were effective in reducing the pain and hardness of

breasts and the former were more effective than the latter in reducing the pain and hardness

of breasts at 2 hours after the second application.

- Both cold cabbage leaves and cold gel packs had no effect on body temperature and the

duration of breastfeeding.

21
- Mothers using cold cabbage leaves were the most satisfied with the breast engorgement care

provided.

ACKNOWLEDGEMENTS
We appreciate the nurses from the study venue who helped with the data collection. We
appreciate the doctors from the study hospital who provided great support to this study. We
thank all mothers who took time to participate in this study. We appreciate the Medical
Publications Support Unit of the National University Health System, Singapore, for assistance in
language editing of this manuscript.

22
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26
 Assessed for eligibility (n=240)

Excluded (n=12):
Declined to participate (n=12)

Baseline measurement (n=228): Demographics, NRSa, BEASb, Oral Thermometer

Randomisation (n=228)

Allocated to cold cabbage
leaves + routine care (n=76)
Received allocated
intervention (n=76)
Did not received allocated
intervention (n=0)
Allocated to cold gel packs +
routine care (n=76)
Received allocated
intervention (n=75)
Did not received allocated
intervention (Reason: baby
admitted to hospital due to
severe jaundice) (n=1)
Allocated to routine care
(n=76)
Received allocated
intervention (n=76)
Did not received allocated
intervention (n=0)

Post-test 1 (6 times Post-test 1 (6 times Post-test 1 (6 times

measurement for all mothers,
immediately after intervention
(n=76): NRSa, BEASb, Oral
Thermometer, ODSSc;
Process evaluation (n=7)
Lost to follow-up (n=0)
measurement for all mothers,
immediately after intervention
(n=75): NRSa, BEASb, Oral
Thermometer, ODSSc;
Process evaluation (n=7)
Lost to follow-up (n=0)
measurement for all mothers,
immediately after intervention
(n=76): NRSa, BEASb, Oral
Thermometer, ODSSc;
Process evaluation (n=21)
Lost to follow-up (n=0)

Post-test 2 (for all mothers, 3 Post-test 2 (for all mothers, 3 Post-test 2 (for all mothers, 3
months after intervention months after intervention months after intervention
(n=75): QM-DBd (n=74): QM-DBd (n=73): QM-DBd
Lost to follow-up (n=1) Lost to follow-up (n=1) Lost to follow-up (n=3)

Post-test 3 (for mothers who
BF at 3 months follow up, 6
months after intervention (n=
55): QM-DBd
Lost to follow-up (n=1)
Post-test 3 (for mothers who
BF at 3 months follow up, 6
months after intervention
(n=56): QM-DBd
Lost to follow-up (n=0)
Post-test 3 (for mothers who
BF at 3 months follow up, 6
months after intervention
(n=53): QM-DBd
Lost to follow-up (n=1)

Per-protocol analysis Per-protocol analysis Per-protocol analysis

Figure 1 CONSORT diagram of this study

Note: aNRS: Numerical rating scale; bBEAS: Breast Engorgement Assessment Scale; cODSS: Ordinal Descriptive
Satisfaction Scale; dQM-DB: Questionnaire for Mothers- Duration of Breastfeeding (3 months and 6 months).

27
Table 1 Comparison of the participants’ sociodemographic characteristics and clinical data
among the three groups (n=227)
Cold cabbage Cold gel Routine
Sociodemographic leaves with packs with only p-value (χ2)
characteristics and clinical routine routine
data (n=76) (n=75) (n=76)
n (%) n (%) n (%)
Age of mother (Mean, SD) 33.4 (4.1) 32.8 (4.3) 32.5(3.9) 0.414 (0.886)a
≤30 years old 17 (22.4) 24 (32.0) 25 (32.9) 0.286 (2.507)
>30 years old 59 (77.6) 51 (68.0) 51 (67.1)
Ethnicity
Chinese 66 (86.8) 61 (81.3) 71 (93.4) 0.084 (4.965)
Non-Chinese 10 (13.2) 14 (18.7) 5 (6.6)
Education
Below Bachelor level 14 (18.4) 21 (28.0) 16 (21.1) 0.347 (2.120)
Bachelor and above 62 (81.6) 54 (72.0) 60 (78.9)
Total Family Income (S$)
<5000 13 (17.1) 11 (14.7) 10 (13.2) 0.837 (1.441)
5001-10000 28 (36.8) 32 (42.7) 35 (46.1)
>10001 35 (46.1) 32 (42.7) 31 (40.8)
Gestational age
Full term 71 (93.4) 70 (93.3) 67 (88.2) 0.407 (1.796)
Pre-term 5 (6.6) 5 (6.7) 9 (11.8)
Baby room in with mother
Yes 63 (82.9) 59 (78.7) 65 (85.5) 0.537 (1.245)
No 13 (17.1) 16 (21.3) 11 (14.5)
Exclusive breastfeeding
Yes 32(34.4) 30(32.3) 31(33.3) 0.965 (0.093)
No 44(32.8) 45(33.6) 45(33.6)
Massage
Yes 33(36.7) 28(31.1) 29(32.2) 0.708 (0.690)
No 43(31.4) 47(34.3) 47(34.3)
Medication for pain relief
Yes 41 (53.9) 37 (49.3) 32 (42.1) 0.338 (2.168)
No 35 (46.1) 38 (50.7) 44 (57.9)
Baseline outcomes (Mean, SD)
Pain 7.6 (1.9) 7.8 (1.8) 7.7(1.9) 0.741 (0.300)a

Hardness 5.4 (0.7) 5.2(0.7) 5.2(0.7) 0.308 (1.183)a

Temperature 37.0 (0.5) 37.0(0.6) 37.1(0.6) 0.286 (1.260)a

a
Analysis of variance, with the F-value (2,224) shown in brackets.

28
Table 2 Comparison of mean outcome variables among the three groups over time for the first
and second applications (n=227)
Effects Wilks Lambda df F p-value
First application: Pain
Group 12.6 2,224 1.06 0.348
Time 0.334 3,222 147.8 <0.001**
Interaction effect (Group*Time) 0.935 6,444 2.52 0.021*
First application: Hardness
Group 1.625 2,224 0.860 0.425
Time 0.333 3,222 148.5 <0.001**
Interaction effect (Group*Time) 0.920 6,444 3.163 0.005**
First application: Temperature
Group 0.628 2,224 0.628 0.535
Time 0.942 3,222 4.562 0.004**
Interaction effect (Group*Time) 0.967 6,444 1.263 0.273
Second application: Pain
Group 30.34 2,224 3.034 0.052
Time 0.211 3,222 276.7 <0.001**
Interaction effect (Group*Time) 0.898 6,444 4.104 0.001**
Second application: Hardness
Group 3.64 2,224 2.128 0.121
Time 0.193 3,222 309.9 <0.001**
Interaction effect (Group*Time) 0.855 6,444 6.013 <0.001**
Second application: Temperature
Group 0.576 2,224 0.920 0.400
Time 0.927 3,222 5.820 <0.001**
Interaction effect (Group*Time) 0.979 6,444 0.782 0.584
Note: *p<0.05; **p<0.01. Repeated measures analysis of covariance was used, adjusted for
baseline values, age, ethnicity, current birth, gestational age (days), education level, and
medication.

29
Table 3 Comparison of pain intensity across the three groups at each time point (n=227)
Time Pain: Mean (SD) F-value p-value# Mean Difference (95% CI)
(2,216) p-value#
C G R C-G C-R G-R
First application 6.75 6.89 7.15 4.03 0.019* 0.01 -0.38 -0.39
- 30 mins (1.9) (1.8) (1.8) (-0.29 to 0.32) (-0.68 to -0.07) (-0.70 to -0.08)
p=0.938 p=0.016* p=0.013*
First application 6.22 6.42 6.72 6.23 0.002** -0.06 -0.48 -0.42
- 1 hour (1.9) (1.7) (2.0) (-0.35 to 0.24) (-0.77 to -0.19) (-0.71 to -0.13)
p=0.710 p=0.001** p=0.005**
First application 5.89 6.25 6.54 6.80 0.001** -0.23 -0.63 -0.41
- 2 hours (1.9) (1.6) (1.9) (-0.57 to 0.12) (-0.97 to -0.29) (-0.75 to -0.06)
p=0.194 p<0.001** p=0.021*
Second application 5.68 6.08 6.34 6.89 0.001** -0.27 -0.61 -0.35
- 30 mins (1.8) (1.6) (1.9) (-0.59 to 0.06) (-0.94 to -0.29) (-0.68 to -0.02)
p=0.110 p<0.001** p=0.038*
Second application 5.18 5.50 5.92 7.62 0.001** -0.22 -0.70 -0.48
- 1 hour (1.6) (1.6) (1.7) (-0.58 to 0.14) (-1.05 to -0.34) (-0.84 to -0.12)
p=0.235 p<0.001** p=0.009**
Second application 4.48 5.11 5.51 13.85 <0.001** -0.53 -0.99 -0.46
- 2 hours (1.4) (1.5) (1.7) (-0.90 to -0.16) (-1.36 to -0.62) (-0.83 to -0.08)
p=0.005 ** p<0.001** p=0.017*
Note: C: Cold cabbage leaves with routine, G: Cold gel packs with routine, R: Routine;
#
Univariate analysis of covariance using General Linear Model, adjusted for baseline values, age, ethnicity, current birth, gestational age (days),
education level, and medication; Pairwise comparisons were Bonferroni adjusted; *p<0.05; ** p<0.01.

30
Table 4 Comparison of the hardness of breasts across the three groups at each time point (n=227)
Time Hardness: Mean (SD) F-value p-value# Mean difference (95% CI)
(2,216) p-value#
C G R C-G C-R G-R
First application 4.71 (0.8) 4.60 (0.7) 4.76 2.89 0.057 -0.03 -0.19 -0.17
- 30 mins (0.7) (-0.2 to 0.15) (-0.36 to -0.02) (-0.34 to -0.06)
p=0.769 p=0.028* p=0.056
First application 4.37 (0.8) 4.33 (0.8) 4.62 8.38 <0.001** -0.10 -0.39 -0.29
- 1 hour (0.8) (-0.30 to 0.10) (-0.59 to -0.20) (-0.49 to -0.09)
p=0.312 p<0.001** p=0.004**
First application 4.27 (0.8) 4.29 (0.8) 4.42 2.70 0.070 -0.14 -0.26 -0.13
- 2 hours (0.9) (-0.36 to 0.09) (-0.49 to -0.04) (-0.35 to 0.10)
p=0.228 p=0.021* p=0.269
Second application 4.21 (0.7) 4.23 (0.8) 4.36 2.70 0.069 -0.13 -0.26 -0.13
- 30 mins (0.8) (-0.35 to 0.09) (-0.48 to -0.04) (-0.35 to 0.10)
p=0.245 p=0.021* p=0.249
Second application 3.81 (0.8) 3.87 (0.9) 4.07 4.34 0.014* -0.16 -0.36 -0.19
- 1 hour (0.8) (-0.40 to 0.08) (-0.59 to -0.12) (-0.43 to 0.05)
p=0.182 p=0.004** p=0.111
Second application 3.41 (0.7) 3.65 (0.8) 3.99 16.26 <0.001** -0.35 -0.66 -0.31
- 2 hours (0.8) (-0.58 to -0.12) (-0.89 to -0.43) (-0.54 to -0.08)
p=0.003** p<0.001** p=0.009**
Note: C: Cold cabbage leaves with routine, G: Cold gel packs with routine, R: Routine;
#
Univariate analysis of covariance using General Linear Model, adjusted for baseline values, age, ethnicity, current birth, gestational age (days),
education level, and medication; Pairwise comparisons were Bonferroni adjusted; *p<0.05; ** p<0.01.

31