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International Journal of Nursing Studies 76 (2017) 92–99



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International Journal of Nursing Studies journal homepage: www.elsevier.com/locate/ijns



Application of cabbage leaves compared to gel packs for mothers with breast engorgement: Randomised controlled trial



MARK



Boh Boi Wonga,b, Yiong Huak Chanc, Mabel Qi He Leowd, Yi Lue, Yap Seng Chongf,g, ⁎ Serena Siew Lin Kohb, Hong-Gu Heb, a



Thomson Medical Centre, Singapore Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore c Biostatistics Unit, National University of Singapore, Singapore d Biomechanics Laboratory, Singapore General Hospital, Singapore e Department of Paediatrics, National University of Singapore, Singapore f Department of Obstetrics and Gynaecology, National University Hospital, Singapore g Yong Loo Lin School of Medicine, National University of Singapore, Singapore b



A R T I C L E I N F O



A B S T R A C T



Keywords: Breast engorgement Cabbage leaves Gel packs Mothers Postnatal Randomised controlled trial



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. 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 min, 1 h, and 2 h 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 min 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 postintervention time points, and mothers in the gel packs group had significant reductions in the hardness of breasts at two time points (1 h and 2 h 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 h 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 breast engorgement, the former had better effect, which can be recommended to postnatal mothers to manage breast engorgement.



What is already known about the topic?



• Breast engorgement is a common physiological problem for lac-



•



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.



tating mothers that may cause breast swelling, pain, fever, and



⁎ Corresponding author at: 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, 117597, Singapore. E-mail addresses: [email protected] (B.B. Wong), [email protected] (Y.H. Chan), [email protected] (M.Q.H. Leow), [email protected] (Y. Lu), [email protected] (Y.S. Chong), [email protected] (S.S.L. Koh), [email protected] (H.-G. He).



http://dx.doi.org/10.1016/j.ijnurstu.2017.08.014 Received 3 January 2017; Received in revised form 6 July 2017; Accepted 24 August 2017 0020-7489/ © 2017 Elsevier Ltd. All rights reserved.



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What this paper adds



(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:



• 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 h after the second application. Both cold cabbage leaves and cold gel packs had no effect on body temperature and the duration of breastfeeding. Mothers using cold cabbage leaves were the most satisfied with the breast engorgement care provided.



1. 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 interstitial oedema during the first congestion (Lawrence and Pane, 2011; 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, 2011; 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, 2011). 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 Janke, 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 sulphur compound in cabbage leaves has antiseptic, disinfectant, anti-bacterial, and anti-inflammatory properties (Hatfield, 2004), which will support their use to relieve pain and swelling. The temperature of cabbage leaves has an impact on its effectiveness



(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 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 3month 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. 2. Methods 2.1. 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). 2.2. 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) 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 93



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



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).



2.5. 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 Rosier (1988), 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 ° Celsius. This method was 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).



2.3. 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 fivehour follow-up 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. 2.4. Intervention 2.4.1. 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.



2.6. Data collection procedure



2.4.2. 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 min or in the fridge for 1 h 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.



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-min, 1-h, and 2-h post first application, and 30-min, 1-h, and 2-h post second application. Satisfaction was obtained at 2-h 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



2.4.3. 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 the freezer for 15 min or in the fridge for 1 h before application. There were two sessions of application. For each session, one gel pack was applied on 94



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



3.2. 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 Fig. 1). 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 Fig. 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 h after the second application (mean difference = 0.53, 95% CI: 0.16-0.9, p = 0.005). As shown in Table 4 and Supplementary Fig. 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 h after the first application and 2 h 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 h after the second application (mean difference = 0.35, 95% CI ranged from 0.12 to 0.58, p = 0.003). Supplementary Table 1 and Supplementary Fig. 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 min 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 min increment for all three groups, except for temperature in the cold cabbage leaves group (rate of change per 10 min 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 min increment. Mothers in the cold gel packs group had significant reductions in pain as measured by the rate of change per 10 min 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.



2.7. 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. 2.8. 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 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 min for pain, hardness, and temperature by groups and also to compare the rate of change across groups. 3. 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. Fig. 1 represents the CONSORT diagram of the study. 3.1. Comparison of sociodemographic and clinical variables of the participants as well as baseline outcomes among the three groups



3.3. Comparison of the duration of breastfeeding among the three groups at 3-month and 6-month follow-ups



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.



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 and 6 months (n = 41, 25%) postpartum. Chi-square tests showed that there 95



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Fig. 1. CONSORT diagram of this study. Note: aNRS: Numerical rating scale; bBEAS: Breast c ODSS: Ordinal Engorgement Assessment Scale; Descriptive Satisfaction Scale; dQM-DB: Questionnaire for Mothers- Duration of Breastfeeding (3 months and 6 months).



Bachelor degree or higher education levels, and with total family monthly incomes of over S$5000. The sample was a representation of the participating hospital’s population. Other local studies have reported similar characteristics, which found that mothers who participated in their studies were generally older and had higher education levels and family incomes (Ong et al., 2014; 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 h after the first application and 2 h 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 h 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,



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. 3.4. 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 Chisquare 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. 4. 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 96



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Table 1 Comparison of the participants’ sociodemographic characteristics and clinical data among the three groups (n = 227). Sociodemographic characteristics and clinical data



Cold cabbage leaves with routine (n = 76) n (%)



Cold gel packs with routine (n = 75) n (%)



Routine only (n = 76) n (%)



p-value (χ2)



Age of mother (Mean, SD) ≤30 years old > 30 years old



33.4 (4.1) 17 (22.4) 59 (77.6)



32.8 (4.3) 24 (32.0) 51 (68.0)



32.5(3.9) 25 (32.9) 51 (67.1)



0.414 (0.886)a 0.286 (2.507)



Ethnicity Chinese Non-Chinese



66 (86.8) 10 (13.2)



61 (81.3) 14 (18.7)



71 (93.4) 5 (6.6)



0.084 (4.965)



Education Below Bachelor level Bachelor and above



14 (18.4) 62 (81.6)



21 (28.0) 54 (72.0)



16 (21.1) 60 (78.9)



0.347 (2.120)



Total Family Income (S$) < 5000 5001–10000 > 10001



13 (17.1) 28 (36.8) 35 (46.1)



11 (14.7) 32 (42.7) 32 (42.7)



10 (13.2) 35 (46.1) 31 (40.8)



0.837 (1.441)



Gestational age Full term Pre-term



71 (93.4) 5 (6.6)



70 (93.3) 5 (6.7)



67 (88.2) 9 (11.8)



0.407 (1.796)



Baby room in with mother Yes No



63 (82.9) 13 (17.1)



59 (78.7) 16 (21.3)



65 (85.5) 11 (14.5)



0.537 (1.245)



Exclusive breastfeeding Yes No



32(34.4) 44(32.8)



30(32.3) 45(33.6)



31(33.3) 45(33.6)



0.965 (0.093)



Massage Yes No



33(36.7) 43(31.4)



28(31.1) 47(34.3)



29(32.2) 47(34.3)



0.708 (0.690)



Medication for pain relief Yes No



41 (53.9) 35 (46.1)



37 (49.3) 38 (50.7)



32 (42.1) 44 (57.9)



0.338 (2.168)



Baseline outcomes (Mean, SD) Pain Hardness Temperature



7.6 (1.9) 5.4 (0.7) 37.0 (0.5)



7.8 (1.8) 5.2(0.7) 37.0(0.6)



7.7(1.9) 5.2(0.7) 37.1(0.6)



0.741 (0.300)a 0.308 (1.183)a 0.286 (1.260)a



a



Analysis of variance, with the F-value (2224) shown in brackets.



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.



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, 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 6month follow-ups. This finding was inconsistent with a previous finding, which was reported by Nikodem et al. (1993), that fewer



4.1. Limitations of the study Although the use of the double-blinded technique would have been ideal for a randomised 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 97



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4.2. Implications for clinical practice



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 Time Interaction effect (Group*Time)



12.6 0.334 0.935



2224 3222 6444



1.06 147.8 2.52



0.348 < 0.001** 0.021*



First application: Hardness Group Time Interaction effect (Group*Time)



1.625 0.333 0.920



2224 3222 6444



0.860 148.5 3.163



0.425 < 0.001** 0.005**



First application: Temperature Group Time Interaction effect (Group*Time)



0.628 0.942 0.967



2224 3222 6444



0.628 4.562 1.263



0.535 0.004** 0.273



Second application: Pain Group Time Interaction effect (Group*Time)



30.34 0.211 0.898



2224 3222 6444



3.034 276.7 4.104



0.052 < 0.001** 0.001**



Second application: Hardness Group Time Interaction effect (Group*Time)



3.64 0.193 0.855



2224 3222 6444



2.128 309.9 6.013



0.121 < 0.001** < 0.001**



Second application: Temperature Group 0.576 Time 0.927 Interaction effect (Group*Time) 0.979



2224 3222 6444



0.920 5.820 0.782



0.400 < 0.001** 0.584



*



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. 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). 4.3. 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. 5. Conclusions



**



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.



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.



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.



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.



Table 3 Comparison of pain intensity across the three groups at each time point (n = 227). Time



Pain: Mean (SD) C



First application − 30 mins First application − 1 h First application − 2 h Second application − 30 mins Second application − 1 h Second application − 2 h



6.75 (1.9) 6.22 (1.9) 5.89 (1.9) 5.68 (1.8) 5.18 (1.6) 4.48 (1.4)



G 6.89 (1.8) 6.42 (1.7) 6.25 (1.6) 6.08 (1.6) 5.50 (1.6) 5.11 (1.5)



F-value (2216)



p-valuea



Mean Difference (95% CI) p-valuea



R 7.15 (1.8) 6.72 (2.0) 6.54 (1.9) 6.34 (1.9) 5.92 (1.7) 5.51 (1.7)



4.03



*



0.019



**



6.23



0.002



6.80



0.001**



6.89



0.001**



7.62



0.001**



13.85



**



< 0.001



C–G



C–R



0.01 (−0.29 to 0.32) p = 0.938 −0.06 (−0.35 to 0.24) p = 0.710 −0.23 (−0.57 to 0.12) p = 0.194 −0.27 (−0.59 to 0.06) p = 0.110 -0.22 (−0.58 to 0.14) p = 0.235 −0.53 (−0.90 to −0.16) p = 0.005**



−0.38 (−0.68 p = 0.016* −0.48 (−0.77 p = 0.001** −0.63 (−0.97 p < 0.001** −0.61 (−0.94 p < 0.001** −0.70 (−1.05 p < 0.001** −0.99 (−1.36 p < 0.001**



G–R to −0.07) to −0.19) to −0.29) to −0.29) to −0.34) to −0.62)



−0.39 (−0.70 p = 0.013* −0.42 (−0.71 p = 0.005** −0.41 (−0.75 p = 0.021* −0.35 (−0.68 p = 0.038* −0.48 (−0.84 p = 0.009** −0.46 (−0.83 p = 0.017*



to −0.08) to −0.13) to −0.06) to −0.02) to −0.12) to −0.08)



Note: C: Cold cabbage leaves with routine, G: Cold gel packs with routine, R: Routine. a 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.



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Table 4 Comparison of the hardness of breasts across the three groups at each time point (n = 227). Time



First application − 30 mins First application − 1 h First application − 2 h Second application − 30 mins Second application − 1 h Second application − 2 h



Hardness: Mean (SD)



F-value (2216)



C



G



R



4.71 (0.8) 4.37 (0.8) 4.27 (0.8) 4.21 (0.7) 3.81 (0.8) 3.41 (0.7)



4.60 (0.7) 4.33 (0.8) 4.29 (0.8) 4.23 (0.8) 3.87 (0.9) 3.65 (0.8)



4.76 (0.7) 4.62 (0.8) 4.42 (0.9) 4.36 (0.8) 4.07 (0.8) 3.99 (0.8)



2.89



p-valuea



Mean difference (95% CI) p-valuea



0.057 **



8.38



< 0.001



2.70



0.070



2.70



0.069



4.34



0.014*



16.26



**



< 0.001



C–G



C–R



−0.03 (−0.2 to 0.15) p = 0.769 −0.10 (−0.30 to 0.10) p = 0.312 −0.14 (−0.36 to 0.09) p = 0.228 −0.13 (−0.35 to 0.09) p = 0.245 −0.16 (−0.40 to 0.08) p = 0.182 −0.35 (−0.58 to −0.12) p = 0.003**



−0.19 (−0.36 p = 0.028* −0.39 (−0.59 p < 0.001** −0.26 (−0.49 p = 0.021* −0.26 (−0.48 p = 0.021* −0.36 (−0.59 p = 0.004** −0.66 (−0.89 p < 0.001**



G–R to −0.02) to −0.20) to −0.04) to −0.04) to −0.12) to −0.43)



−0.17 (−0.34 p = 0.056 −0.29 (−0.49 p = 0.004** −0.13 (−0.35 p = 0.269 −0.13 (−0.35 p = 0.249 −0.19 (−0.43 p = 0.111 −0.31 (−0.54 p = 0.009**



to −0.06) to −0.09) to 0.10) to 0.10) to 0.05) to −0.08)



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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. 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. Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/j.ijnurstu.2017.08.014. References Arora, S., Vatsa, M., Dadhwal, V., 2008. A comparison of cabbage leaves vs. hot and cold compresses in the treatment of breast engorgement. Indian J. Community Med. 33 (3), 160–162. http://dx.doi.org/10.4103/0970-0218.42053. Boyce, S., 2009. Ice/cryotherapy and management of soft tissue injuries. Emerg. Med. J. 26 (1) 76–76. Chiu, J., Gau, M., Kuo, S., Chang, Y., Tu, H., 2010. Effects of Gua-Sha therapy on breast engorgement: a randomised controlled trial. J. Nurs. Res. 18 (1), 1–10. Chua, L., Win, A.M., 2013. Prevalence of Breastfeeding in Singapore. http://www. singstat.gov.sg/docs/default-source/default-document-library/publications/ publications_and_papers/health/ssnsep13-pg10-14.pdf. (Accessed 13 June 2015). Cohen, J., 1992. A power primer. Psychol. Bull. 112 (1), 155–159. Findlay, A.L.R., 1996. Sensory discharges in lactating mammary glands. Nature 211, 1183–1184. Foo, L.L., Quek, S., Ng, S., Lim, M., Deurenberg-Yap, M., 2005. Breastfeeding prevalence and practices among Singapore Chinese, Malay and Indian mothers. Health Promot. Int. 20 (3), 229–237. Hatfield, G., 2004. Encyclopaedia of Folk Medicine: Old World and New World Traditions. ABC-CLIO, California, pp. 59–60. He, H.G., Zhu, L.X., Chan, W.C.S., Xiao, C.X., Klainin-Yobas, P., Wang, W., Cheng, K.F.K., Luo, N., 2015. A randomised controlled trial of the effectiveness of an educational intervention on outcomes of parents and their children undergoing inpatient elective surgery: study protocol. J. Adv. Nurs. 71 (3), 665–675. http://dx.doi.org/10.1111/ jan.12521. Joy, J., 2013. A Study to Evaluate the Effectiveness of Chilled Cabbage Leaves Application



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