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NCT07021469

Sound Origins Acceptability Study

Sponsor: King's College London

View on ClinicalTrials.gov

Summary

The goal of this study is to assess the acceptability and accessibility of a co-designed music therapy intervention for parents with infants with uncertain futures and nursing staff on the neonatal unit. The main questions it aims to answer are: 1. To assess the acceptability and accessibility of the co-designed music therapy intervention 2. To assess the frequency of recruitment and retention of the participants 3. To assess the feasibility of the creation and sharing of a musical gift within 1 week 4. To assess the appropriateness of the timeframe for interview of parents who experience neonatal death during the study timeframe. Participants will test an intervention comprising of: 1. Playlists created by parents with lived experience for parents to use as ideas for music they could use for themselves or with baby on the unit. This is shared via QR code in a journal and on the study website which will be provided at the time of the consent. 2. Parent Journal: This journal provides a guide for using music and self-reflection. It also has the link for the playlists. 3. 'Musical gifts' created with the support of a music therapist from external family/ friends to the baby on the unit. Contact will be on MsTeams with individual age 18 or over or supported by an adult. Music will be created by contact to send direct to family on the neonatal unit as a voice note. If requested the family may send a voice note to the music therapist to then add to to make more complex music using 'Audacity' software to then be returned to the contact via 'we transfer' for approval before sharing with the family on the unit. 4. Nurses shared playlist: This is a playlist for nursing staff to create their own shared playlist using their music. 5. 'Ask me' badges. These badges are optional for nurses to wear during their shifts but will act as a symbol to parents that their nurse is available to speak to about music

Official title: Sound Origins: Assessment of the Acceptability and Accessibility of a Co-designed Music Therapy Intervention

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2025-09-01

Completion Date

2026-06-30

Last Updated

2025-06-15

Healthy Volunteers

Conditions

Accessibility and Acceptability of Intervention

Interventions

OTHER

Sound origins

Parents: 1. Playlists created by parents with lived experience for parents to use as ideas for music they could use for themselves or with baby on the unit. 2. Parent Journal: This journal provides a guide for using music and self-reflection. It also has the link for the playlists. 3. 'Musical gifts' created with the support of a music therapist from external family/ friends to the baby on the unit. Nursing staff caring for families participating in the study: 1. Nurses shared playlist. Suggested creation of 3 playlists for nursing staff to create their own shared playlist using their music. 2. 'Ask me' badges. These badges are optional for nurses to wear during their shifts but will act as a symbol to parents that their nurse is available to speak to about music.

Inclusion Criteria: Parent inclusion criteria: 1. 18+ years 2. Has an infant diagnosed with a condition meeting the infant inclusion criteria on admission to the unit (see below) 3. Can give informed consent Healthcare professional inclusion criteria: 1. Nursing professional working with or providing support to parents with infants diagnosed with a life limiting condition involved in the study 2. Part time, full time on UCLH neonatal unit 3. Any grade Infant inclusion In accordance with Together for short lives neonatal palliative care guidelines any parent who has an infant meeting the following criteria whilst on the neonatal unit will be eligible for the intervention: Category 1: Life-threatening conditions for which curative treatment may be feasible but can fail Provision of palliative care services may be necessary when treatment fails or during an acute crisis, irrespective of the duration of threat to life. On reaching long-term remission or following successful curative treatment there is no longer a need for palliative care services. Examples: extreme prematurity, severe necrotising enterocolitis, congenital heart disease. Category 2 Conditions where premature death is inevitable. There may be long periods of intensive treatment aimed at prolonging life and allowing participation in normal activities. Example: chromosomal abnormality, severe spina bifida, bilateral multi-cystic dysplastic kidneys, bilateral renal agenesis. Category 3 Progressive conditions without curative treatment options Treatment is exclusively palliative and may commonly extend over many years. Example: skeletal dysplasia, severe neuromuscular disorders. Category 4 Irreversible but non-progressive conditions causing severe disability, leading to susceptibility to health complications and likelihood of premature death. Example: severe hypoxic ischaemic encephalopathy. Exclusion Criteria: Parent exclusion criteria 1. \<18+ years 2. Acute mental health diagnosis e.g schizophrenia, psychosis 3. Substance abuse 4. Does not have an infant meeting inclusion criteria 5. Unable to provide consent Healthcare professional exclusion criteria 1. not working with or providing support to parents with infants diagnosed with a life limiting condition 2. agency staff

Locations (2)

Kings College London

London, Professor, United Kingdom

University College London Hospital Neonatal Unit

London, United Kingdom