Cited by 1Maternal Mental Health During Pregnancy and PostpartumMusic Therapy and HealthMaternal and Perinatal Health Interventions

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Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers

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Colella, Corinna A., McNeill, Jenny, McCann, Una, Lynn, Fiona A.·2025·Pilot and Feasibility Studies

Published version of a preprint

Abstract

Background: Postnatal mothers can experience anxiety, stress and difficulty with mother-infant attachment with potential to lead to an anxiety disorder/depression. There has been an increase in interest in non-pharmacological interventions involving music, with limited evidence assessing effectiveness in this population within randomised controlled trials (RCTs). Mamas in Harmony is a novel music/social support intervention. The objective is to assess the feasibility/acceptability of conducting a full RCT to test the effect and cost-effectiveness of Mamas in Harmony compared with usual care. Methods: The pilot RCT aims to recruit 60 mother-infant dyads through social media, community organisations and stakeholder networks, randomly allocated on a 2:1 ratio to the intervention and control group. The intervention group will receive eight 1 h weekly Mamas in Harmony sessions plus usual care, and the control group will receive usual care only. Feasibility measures include recruitment, retention and attendance at intervention sessions. The process evaluation aims to establish acceptability of the intervention involving survey evaluation and semi-structured interviews. A priori guidelines have been agreed to establish criteria for progression to a definitive RCT. Discussion: The current evidence supports the use of music in reducing anxiety and stress with the recommendation for inclusion of social support. This study has potential to provide robust evidence of the feasibility and acceptability of a music and social support mother-infant group intervention in preparation for a future definitive trial, should progression criteria be met. Trial registration: ClinicalTrials.gov ID: NCT05930990 , registered retrospectively on 5 July 2023. Recruitment commenced on 16 March 2023. Protocol version: 30 October 2023 Vn 1.0

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Metadata

Authors
Colella, C. A., McNeill, J., McCann, U., & Lynn, F. A.
Affiliations
Queen's University Belfast (GB)
Corresponding author
Colella, Corinna A.
Venue
Pilot and Feasibility Studies
Published
2025-04-10
Volume
11
Issue
1
Pages
44-44
ISSN
2055-5784 (ISSN-L)
OpenAlex
W4409344976
Cited by
1
References
10
Citations by year
2025: 1
FWCI
0.91
Type
journal article
Language
en
Open access
Locations
  • Pilot and Feasibility Studies (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Research Portal (Queen's University Belfast) (submittedVersion, cc-by)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
  • Social Sciences › Psychology › Social Psychology › Music Therapy and Health
  • Health Sciences › Medicine › Obstetrics and Gynecology › Maternal and Perinatal Health Interventions
Keywords
postpartum anxiety, postpartum stress, music intervention, social support, maternal attachment, postpartum depression, non-pharmacological treatment, group intervention, feasibility, acceptability, cost-effectiveness

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