Sound Origins: Assessment of the Acceptability and Accessibility of a Co-designed Music Therapy Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 3
- 主要终点
- Acceptability Questionnaire
研究概览
简要总结
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:
- To assess the acceptability and accessibility of the co-designed music therapy intervention
- To assess the frequency of recruitment and retention of the participants
- To assess the feasibility of the creation and sharing of a musical gift within 1 week
- 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:
- 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.
- Parent Journal: This journal provides a guide for using music and self-reflection. It also has the link for the playlists.
- '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.
- Nurses shared playlist: This is a playlist for nursing staff to create their own shared playlist using their music.
- '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
详细描述
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:
- 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.
- explanation of a website and parent playlists
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent inclusion criteria:
- •Has an infant diagnosed with a condition meeting the infant inclusion criteria on admission to the unit (see below)
- •Can give informed consent
- •Healthcare professional inclusion criteria:
- •Nursing professional working with or providing support to parents with infants diagnosed with a life limiting condition involved in the study
- •Part time, full time on UCLH neonatal unit
- •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.
排除标准
- •Parent exclusion criteria
- •<18+ years
- •Acute mental health diagnosis e.g schizophrenia, psychosis
- •Substance abuse
- •Does not have an infant meeting inclusion criteria
- •Unable to provide consent
- •Healthcare professional exclusion criteria
- •not working with or providing support to parents with infants diagnosed with a life limiting condition
- •agency staff
结局指标
主要结局
Acceptability Questionnaire
时间窗: Parents will be assessed after completing the intervention for 3 weeks. Staff will complete the questionnaire at the end of the full study duration. This will be either after 4 months or when 12 parents have participated whichever is first.
A non-validated questionnaire developed by the researchers will assess the acceptability of the intervention based on domains from Sekon's Theoretical Framework of Acceptability. The framework includes the following domains: Affective attitude, burden, ethicality, perceived effectiveness, opportunity cost, intervention coherence, self-efficacy. These will be assessed through one questionnaire.
次要结局
- Neuroception of psychological safety scale- NPSS(Days 1 and 16)