Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-31 @ 6:59 AM
Study NCT ID:
NCT07021469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sound Origins Acceptability Study
Sponsor:
King's College London
Organization:
Study Overview
Official Title:
Sound Origins: Assessment of the Acceptability and Accessibility of a Co-designed Music Therapy Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Soundorigins
Brief 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
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
Detailed Description:
Testing a co-designed music therapy intervention:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: