| Author: | Chen, Li Sha |
| Title: | The effects of auricular therapy on lactation : a preliminary study |
| Degree: | DHSc |
| Year: | 2020 |
| Subject: | Lactation Ear -- Acupuncture Hong Kong Polytechnic University -- Dissertations |
| Department: | Faculty of Health and Social Sciences |
| Pages: | xv, 141 pages : color illustrations |
| Language: | English |
| Abstract: | Background: Cesarean section has been recognized as a risk factor for delayed onset of stage II lactogenesis, which in turn could lead to early weaning from breastfeeding. Additional support is often needed to address the challenges and potential adverse effects posed by cesarean section on lactation and breastfeeding. Given the health benefits of breastfeeding and increasing cesarean rates globally, rigorously evaluation into the application of auricular therapy (AT) as an adjuvant intervention for facilitating lactation after cesarean delivery is relevant to lactating women and health care providers worldwide. Aim: This study aimed to assess the feasibility of applying an evidence-based standard AT protocol on facilitating lactation after cesarean delivery and to preliminarily examine the effectiveness of AT on lactation for the purpose of evaluating whether a future full study is worthwhile. Design: A three-arm randomized controlled design that included a standard care group, a sham AT group, and a true AT group. Participants in the sham and the true AT groups, as well as the hospital staff, were blinded to the group allocation. Participants and setting: Women who had no major medical or obstetrical conditions gave birth to full-term singletons via cesarean sections at a local maternal hospital in southern Taiwan. Intervention: Participants were randomized into three groups: those in the standard care group received the usual standard post-cesarean care, those in the sham AT group received standard care in addition to 96 hours of sham AT using medulla junci, and those in the true AT group received standard care in addition to 96 hours of true AT using magnetic pellets. AT interventions and outcome assessments began within 8 hours after birth and were carried out for a total of five postoperative days. Measures: All participants were asked to note the time of milk "coming in" as indicated by sensations of breast fullness, swelling, tingling, or milk leakage. Daily milk yield was determined by adding daily infant test weight to the expressed breast milk volume for each consecutive 24-hour period after birth. Known confounders of lactation after cesarean delivery were collected via interviews and medical records. Daily pain and stress ratings were assessed using the numeric rating scale (NRS 0-10) to evaluate their possible mediating or moderating effects on the relationship between AT treatment and milk production. Participants in the true AT and the sham AT groups were asked to rate their treatment expectations before the commencement of AT. Effect perception, acceptability, and credibility questions were assessed after completion of 96 hours of AT. Data analysis: Descriptive statistics were used to describe the characteristics of the participants and evaluate the feasibility of conducting a full trial. Survival analyses using the Kaplan-Meier (KM) method and cox regression were employed to generate and compare the survival distribution functions for the timing of maternal perception for the onset of lactogenesis II among study groups. Generalized estimating equation (GEE) was utilized to compare any differences among study groups in daily amount of breast milk over the first five days postpartum. Then, the 5-day milk total was tested as a single observation for each participant using a generalized linear model (GLM). Regression using SPSS macro PROCESS was performed to determine whether 5-day average pain or stress levels moderated or mediated the relationship between AT treatment and total breast milk volume. Results: A total of 96 post-cesarean women were recruited, and 92 of them completed all of the AT treatments and outcome assessments. The attrition rate of the study was 4.2% (4/96). Data from the four participants who left the study prematurely were included in the analysis as randomized or using the principal of last observation carried forward (LOCF). After excluding six participants with extreme breast milk yields, a final total of 90 women were included in the data analysis (standard care=30; sham AT=28; true AT=32). The average credibility (Mdn=10.00, n=32, true AT group; Mdn=9.00, n=28, sham AT group) and acceptability (Mdn=7.00, n=32, true AT group; Mdn=6.00, n=28, sham AT group) ratings on the NRS (0-10) indicated that the use of AT as an adjuvant intervention for post-cesarean lactation was acceptable to the majority of participants. The treatment expectations, which were evaluated prior to the commencement of AT, did not reveal a significant difference between participants in the true and the sham AT groups (U=338.5, z= -1.808, p=0.71). Whereas the effect perceptions, which were assessed after completion of 96 hours of AT, did (t [56] = -2.601, p=0.012). The difference in effect perceptions were consistent with the clinical observation of breast milk yields. That is, participants in the sham AT group produced less milk (mean of 5-day total breast milk volume=254.30 ml, SD=227.86) and also perceived fewer effects from AT when compared to the true AT group (mean of 5-day total breast milk volume=366.94 ml, SD=220.37). Adverse reactions associated with AT, i.e., minor to moderate tenderness and itchiness on the auricle site being treated, were reported by nine participants (true AT=6; sham AT=3). No additional intervention was needed as these discomforts gradually subsided after the removal of the auricular objects. Maternal perception of the onset of lactogenesis II, as signaled by breast sensations or symptoms such as fullness, swelling, tingling, or milk leakage, was not different significantly in the onset of their occurrence among the three groups, X2(2)=0.231, p=0.891. Daily milk yield, as calculated by adding daily infant test weight to the amount of daily expressed breastmilk, did not differ by group during the first five days after delivery (Wald X2=6.890, p=0.549). The most significant finding in this study was that in cases where average pain scores over five days were ≤3.80 on the numeric rating scale (NRS 0-10), there was a moderating effect of pain on the relationship between AT treatment and milk production (R2 =0.2477, F(4, 55)=4.53, p<0.0031). This means that women in the true AT group yielded more breast milk than their counterparts in the sham group when the average pain score was at a low level. More sustained breastfeeding, i.e., exclusive breastfeeding at one and three-months after birth, occurred in participants who received the true AT than those in the other two groups, although a statistically significant difference was not detected, X2(4, n=90)=3.201, p=0.525, and X2(4, n=90)=1.110, p=0.894, respectively. These results provide preliminary evidence suggesting that AT can have a positive effect on post-cesarean lactation. Data generated from this preliminary study allows the estimation of 60 participants in each group for a potential future study. Conclusion: Preliminary evidence from this study suggests that the use of AT as a supportive measure for facilitating lactation after cesarean delivery was well-accepted by the majority of participants. The evidence-based standard AT protocol was feasible and could be implemented easily in clinical practice. This study provides new sight by identifying the moderating effect of pain on the relationship between AT and post-cesarean milk production. AT appears safe with respect to its potential adverse effects. Additional fully powered research is warranted to gather more definite evidence on the effectiveness of AT on postpartum lactation and to explore its potential mechanism of action. |
| Rights: | All rights reserved |
| Access: | restricted access |
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