Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
132 participants
INTERVENTIONAL
2025-09-01
2026-06-30
Brief Summary
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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
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Detailed Description
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This study will aim to test a co-designed music therapy interventions with 12 parents of 12 infants with uncertain futures at University College London hospital and the nurses that care for them during this period.
Parents will be approached by the lead researcher, research nurse or lead consultant about participating in the study. They will be given information sheets outlining what will be expected and the potential burdens and benefits of taking part. They will be given 24hrs to consider the study before providing consent. The lead researcher will then approach to gain consent and answer any questions on the study. If consent is given, the cot side nurse will provide the family with the journal and make a referral to music therapy. A meeting with the unit music therapist will then be made and the following discussed:
1. contact with a nominated person off the unit to create a musical gift for the baby (external contact will need to be age 18 or over, siblings/ children can be included if supported by an adult). Meeting held via MSTeams.
2. explanation of a website and parent playlists
3. a journal
After the music therapist has worked with the external contact and a musical gift created (likely to be a lullaby) it will be sent to the family either by the family contact or the music therapists as preferred by the parent. On day 7 of the study the music therapist will check in with the parent on the unit to review the materials and offer further support. Journal entries will not be shared with any member of staff or the researcher unless parents wish to. Parents can then chose to continue support or use the resources independently.
During the study period parents will be asked to complete questionnaires assessing psychological safety (Neuroception of psychological safety scale NPSS-G). These will be completed on the unit on day 1 and 16 of the study via hardcopy. Once completed, parents can leave with the reception in a sealed envelope (provided). This will then be stored in a locked research cabinet until the lead research is able to collect. Separately, nursing staff involved in the care of these babies will be encouraged to build a shared playlist to support staff relationships and regulation through music. They will be sent a digital link to the website which gives instruction and guide to engagement with families through music as well as advise on building a staff playlist. They will also be provided with 'ask me' badges to wear to signal their availability to parents that they are happy to engage in conversation about the parents use of music and the value of certain music to their family.
Evaluation of acceptability:
At the end of the study period (3 weeks) parents will be asked to complete an acceptability survey and attend a short interview. Where a baby has died parents will be contacted 6 weeks after the death to consent their continued participation in the study and completion of the survey and interview. The lead researcher will contact parents to arrange a time for a short interview either at the parents home or at a University College London Hospital research room to discuss the acceptability of the intervention further. Similarly health care professionals will also be ask to complete an acceptability survey at the end of the intervention being testing on the unit (4 months) and encouraged to give feedback on their use of the playlist and the 'ask me' badges. Prior to completing the questionnaire they will be required to complete a consent form where they can tick if they would like to be contacted to participate in an online focus group to discuss their experiences further. Those who chose to do this will be provided with an overview of the topics for discussion prior to the group.
Celebration event:
A celebration event will be held at King's Place, London to celebrate the development of the intervention and the value of the engagement from everyone who has been involved at all stages. Everyone involved at any stage of the research will be invited to this event. It will also be extended to healthcare professionals and family support charities.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Parent and staff participants
Parents with infants with uncertain futures on admission to the neonatal unit and the nurses caring for them.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
3. Can give informed consent
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.
5. Unable to provide consent
Exclusion Criteria
2. Acute mental health diagnosis e.g schizophrenia, psychosis
3. Substance abuse
1. not working with or providing support to parents with infants diagnosed with a life limiting condition
2. agency staff
18 Years
70 Years
ALL
No
Sponsors
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King's College London
OTHER
Responsible Party
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Principal Investigators
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Glenn Robert, PhD
Role: STUDY_CHAIR
King's College London
Kirsty Jane
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Kings College London
London, Professor, United Kingdom
University College London Hospital Neonatal Unit
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Jane K, Wood D, Gallagher K, Livermore P, Shoemark H, Robert G. Parents' experiences of psychotherapeutic support on the neonatal unit: A mixed methods systematic review to inform intervention development for a multicultural population. Nurs Crit Care. 2025 May;30(3):e13194. doi: 10.1111/nicc.13194. Epub 2024 Oct 28.
Standley J. Music therapy with premature infant: Research and developmental interventions. Music Therapy Perspectives. 2003;23(1):76-8.
Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
Flaks MK, Malta SM, Almeida PP, Bueno OF, Pupo MC, Andreoli SB, Mello MF, Lacerda AL, Mari JJ, Bressan RA. Attentional and executive functions are differentially affected by post-traumatic stress disorder and trauma. J Psychiatr Res. 2014 Jan;48(1):32-9. doi: 10.1016/j.jpsychires.2013.10.009. Epub 2013 Oct 22.
Al Maghaireh DF, Abdullah KL, Chan CM, Piaw CY, Al Kawafha MM. Systematic review of qualitative studies exploring parental experiences in the Neonatal Intensive Care Unit. J Clin Nurs. 2016 Oct;25(19-20):2745-56. doi: 10.1111/jocn.13259. Epub 2016 Jun 3.
Fraser. L. G-SD, Jarvis. D., Norman. P., Parslow. R., . 'Make Every Child Count' Estimating current and future prevalence of children and young people with life-limiting conditions in the United Kingdom. Together for Short Lives. 2020.
NCMD. NCMD Second Annual Report. Child Death Review Data. 2021.
Dickson G. A Perinatal Pathway for Babies with Palliative Care Needs, 2nd Edition. Together for Short Lives. 2019.
Related Links
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Sound Origins Study, King's College London
Other Identifiers
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355379
Identifier Type: -
Identifier Source: org_study_id
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