Protocol for RCT: Effectiveness of Traditional Breast Stimulations as Adjuvant Techniques to Breast Milk Expression on Lactational and Maternal Outcomes

Background: Mothers of infants who are dependent on expressed breast milk often find difficulty to express adequate quantity of breast milk to ensure exclusive breast feeding to their babies and it has become a major stress factor among these mothers. Many cost-effective adjuvant techniques are proved to be very useful in improving the quantity and quality of expressed breast milk.

Objective: To determine the effect of two traditional breast stimulation techniques such as warm compress and breast massage as adjuvant to breast milk expression on maternal and lactational outcomes.

Methodology: A hospital-based cross over trial will be considered to compare the effects of two interventions such as breast massage and warm compress, adjuvant to breast milk expression method (breast pump) on lactational outcomes (Quantity and quality of expressed breast milk) and maternal outcomes (Nipple pain, anxiety and experience of breast milk expression). The setting of the study will be selected tertiary level hospital of New Delhi. Approval from Institutional the Ethical approval is obtained from Institutional Ethical Committee, DMIMS (DMIMS (DU)/IEC/2017-18/6979) and also from the institutional ethical committee of armed forces medical services hospital of New Delhi where the study will be conducted. The data collected will be entered to an electronic data sheet and analysis will be done using SPSS.

Expected Results: There will be a positive impact of interventions on locational outcomes such as quantity of expressed breast milk and quality of expressed breast milk.

There will be a positive impact of interventions on maternal outcomes such as nipple pain. Anxiety and breast milk expression experience.

This nurse led interventions will be made as a part of hospital policy to provide routine care to the mothers who are expressing breast milk in hospital settings.

Conclusion: Conclusion will be drawn after the analysis of data collected from the predetermined sample size. The findings of the study will be published in an open access peer reviewed journal.