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Feasibility Study of a Music and Social Support Intervention for Postnatal Mothers/Infants

NCT05930990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-07-03

No results posted yet for this study

Summary

This research study aims to assess the feasibility of conducting a full scale trial of Mamas in Harmony, a group music and social support class delivered by a professional musician for mothers and their babies. Classes for Mamas in Harmony run for 1 hour each week for 8 weeks at a community venue with 10-12 mothers and babies in each class.

The aim of this study is to conduct a pilot randomised controlled trial and process evaluation to assess recruitment rate, retention rate, adherence rate to the study protocol, attendance rate for the intervention, completion rate of outcome measurement tools, acceptability of the intervention, and barriers/facilitators for study participation and intervention delivery.

This feasibility study aims to recruit 60 mothers and babies. Forty will be randomly allocated to the intervention group of Mamas in Harmony and receive standard postnatal care and twenty will receive standard postnatal care only, as the control group.

All mothers will be asked to complete study questionnaires at three time points over a 6 month period to assess their mental health and wellbeing and bonding with their baby.

Mothers will also be asked if they wish to share their opinions and experiences about the research study and Mamas in Harmony classes (if they were allocated to that group) in an interview, to provide their thoughts, whether anything made it easy/difficult for them to participate and whether they have any suggestions on how to improve the study procedure.

The musician will also be asked for their experiences on the barriers and facilitators of intervention delivery.

Conditions

Interventions

BEHAVIORAL

Mamas in Harmony

Mothers attend 8x 1 hour weekly classes with their infant. Classes take place in a community venue. Mothers sit with their infant on the floor in circle formation on cushioned mats. Group singing facilitated for 40 minutes by the intervention facilitator, a professional musician/choir leader. A mix of songs are introduced that are easy to learn without the need for lyric sheets. Mothers will be encouraged to sing along. Mothers will be encouraged to interact with their infant through various sensory stimuli involving touch, sound and visual. The end of each singing session involves a short period of quiet time, soothing sounds are provided by the intervention facilitator using voice and instruments. 20 minutes of facilitated social support will follow and mothers will be provided with refreshments. Mothers will be encouraged to interact with other mothers to promote social connection.

Sponsors & Collaborators

  • Queen's University, Belfast

    lead OTHER

Principal Investigators

  • Fiona A Lynn, PhD · Queen's University, Belfast

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-16
Primary Completion
2024-04-12
Completion
2024-04-12

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05930990 on ClinicalTrials.gov