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. 2017 Jul 14:12:33.
doi: 10.1186/s13006-017-0124-y. eCollection 2017.

Study protocol: An investigation of mother-infant signalling during breastfeeding using a randomised trial to test the effectiveness of breastfeeding relaxation therapy on maternal psychological state, breast milk production and infant behaviour and growth

N H M Shukri  1   2   3 , J Wells  1 , F Mukhtar  2   4 , M H S Lee  2   3 , M Fewtrell  1
Affiliations

Study protocol: An investigation of mother-infant signalling during breastfeeding using a randomised trial to test the effectiveness of breastfeeding relaxation therapy on maternal psychological state, breast milk production and infant behaviour and growth

N H M Shukri et al. Int Breastfeed J. .

Abstract

Background: The physiological and psychological signalling between mother and infant during lactation is one of the prominent mother-infant factors that may influence breastfeeding outcomes. The infant can 'signal' his needs through vocalisation, and the mother can respond by allowing or restricting nipple access, which might alter the breast milk composition or volume. This may lead to parent-offspring conflict during the lactation period. Challenging infant behaviour has also been associated with maternal psychological distress, which might affect breastfeeding performance. Most attempts to improve breastfeeding rates focus on providing additional support, yet many aspects of the breastfeeding process are poorly understood. Thus, our objective is to investigate mother-infant signalling during breastfeeding by manipulating maternal psychological state using a relaxation therapy intervention. The study will test the hypothesis that mothers who listen to the therapy will be more relaxed/less stressed and this will favourably alter breast milk composition and/or affect milk volume and hence influence infant outcomes.

Methods: A randomised controlled trial will be conducted in first-time breastfeeding mothers and their new-born infants. Pregnant mothers will be recruited at antenatal clinics in Selangor, Malaysia, and four home visits will be carried out at 2, 6, 12 and 14 weeks postnatally. Participants will be randomised into a control and an intervention group in the early post-partum period. Mothers from the intervention group will be asked to listen daily to an audio recording with relaxation therapy during breastfeeding. Maternal psychological state, breastfeeding practices and infant behaviour will be assessed using validated questionnaires. Milk volume will be measured using stable isotopes. Breast milk samples will be collected to measure macronutrient content and hormone levels. Anthropometric measurements (weight, length and head circumference) will be performed during all home visits, including body composition at week 14.

Discussion: The main outcomes will be the effect of the intervention on maternal psychological state, milk production, cortisol levels, and infant behaviour and growth. Secondary outcomes will be associations between breast milk composition and infant appetite and growth. This study aims to provide a greater understanding of maternal-infant factors which influence breastfeeding outcomes and which may be useful targets for future interventions.

Trial registration: ClinicalTrials.gov identifier: NCT01971216.

Keywords: Breastfeeding; Infant behaviour; Infant growth; Maternal stress; Mother-infant signalling; Relaxation therapy.

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Conflict of interest statement

Ethics approval and consent to participate

The trial has obtained ethics approval from the Medical Research Ethics Committee (MREC), Ministry of Health Malaysia (ID: 13–841-16,720) and UCL Ethics Committee, London, UK (ID: 4883). The MOM Study has also been registered with the Malaysian National Medical Research Register (NMMR ID: 16,720) and ClinicalTrials.gov (ID: NCT01971216). This research project is performed in collaboration with the Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM). During recruitment the researcher will check the participants’ understanding of the information sheet and ensure that they understand that their individual details and responses will remain confidential. A signed written consent form will be obtained from all mothers at recruitment at the antenatal clinics. Mothers who do not wish to continue with the study can withdraw at any point during the study. If a subject withdraws from the study, permission will be sought to use data already collected. Participants will be informed that all information is strictly confidential and all data will be kept in a locked filing cabinet at the study centre in Malaysia or UK. Electronic data will be stored on the researcher’s or study centre’s computer in files that will be password protected.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Overview of the MOM Study plan
Fig. 2
Fig. 2
Recruitment, enrolment and randomisation process
Fig. 3
Fig. 3
Data collection processes and procedures
See this image and copyright information in PMC

References

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