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.
Corinna A Colella, Jenny McNeill, Una McCann, Fiona A Lynn
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引用次数: 0
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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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