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临床试验/NCT06844396
NCT06844396已完成不适用

The Impact of NICU Music Therapy on Preterm Infants' Clinical Markers and Caregiver Wellbeing

Anglia Ruskin University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Infant Temperature

研究概览

简要总结

This study aims to provide initial evidence for the use of music therapy in the NICU in a UK context. In other countries, such as the US and the Netherlands, music therapy is routinely provided in the NICU and research has demonstrated benefits for the both the child and their caregivers. As there is no existing UK-based research on music therapy in the NICU, medical institutions are reluctant to consider the benefits of music therapy. This reduces infants' access to non-invasive treatment in the NICU. Our study aims to address this gap.

详细描述

The aim of this pilot study is to investigate the impact of Neonatal Intensive Care Unit (NICU) Music Therapy (MT) interventions on preterm infants' clinical markers and caregiver wellbeing. The study will investigate changes in the participating infants' clinical markers (heart rate, oxygen saturation, blood pressure, respiration rate) before, during and after therapy, weight gain, feeding behaviours, sleep patterns, discharge time and caregiver wellbeing, including bonding and mood. The study also aims to assess the acceptability of music therapy for pre-term infants, caregivers and NICU staff, and explore how music therapy can be used on NICU wards in the UK.

NICU care, while lifesaving, has been shown to have negative long-term consequences, which can include repeated activation of the stress response and reduced maternal interaction, with possible negative long-term impacts on brain development.

The NHS published an action plan to implement recommendations for improving neonatal care. The report does not specify music therapy. However, initial research in the US, Switzerland, and the Netherlands has shown clinically and statistically significant improvements on well-being, stress reduction and neural development in the neonate. Beyond these crucial findings, music therapy had a positive effect on parent well-being, parent-child interaction and the overall reduction of noise levels on the ward.

This pilot study will consist of a six-week data collection period. During this time, infants and their primary caregiver(s) will be invited to participate in the study on admission to the NICU.

Participants will be offered music therapy sessions twice weekly over the course of the six-week data collection period. The music therapist will determine the appropriate music therapy interventions according to the infant's needs, therapeutic goals and corrected gestational age. These could include one of the four interventions from the NICU-MT method depending on therapeutic need, 1) music combined with caregiver skin to skin, 2) developmental multimodal technique, 3) infant directed singing and 4) caregiver therapeutic support. The caregiver may also be involved in the session during the use of multimodal technique, infant directed singing, and caregiver skin to skin. Sessions will last approximately 30 minutes, with 10 - 20 minutes of music.

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
28 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Infant Participants:
  • Inclusion Criteria:
  • Infants in or admitted to the Whittington NHS Trust NICU High Dependency Unit (HDU) during the 6-week intervention and data collection period
  • Infants are medically stable
  • Infants at 28 weeks corrected gestational age and above

排除标准

  • Infants who are medically unstable
  • Infants younger than 28 weeks CGA
  • Severe hearing impairment or hearing loss
  • Primary Caregivers:
  • Inclusion criteria:
  • Primary caregiver(s) of an infant participating in the study
  • Ability to complete questionnaires in English
  • Inclusion criteria:
  • 1 month experience working at the Whittington NHS Trust NICU
  • At least two days' experience working on music therapy service provision days during the intervention period

研究组 & 干预措施

Music Therapy

Experimental

Music Therapy delivered twice weekly to infants on a NICU ward

干预措施: Music Therapy (Other)

结局指标

主要结局

Infant Temperature

时间窗: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally

Routinely collected clinical data will be collected for each infant participant to include temperature reported at degrees celcius. The data is collected using Nellcor/Covidien monitors

Infant Heart Rate

时间窗: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally

Routinely collected clinical data will be collected for each infant participant to include heart rate reported in beats per minute. The data is collected using Nellcor/Covidien monitors

Infant Respiratory Rate

时间窗: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally

Routinely collected clinical data will be collected for each infant participant to include respiratory rate reported in breaths per minute. The data is collected using Nellcor/Covidien monitors

Infant Oxygen Saturation

时间窗: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally

Routinely collected clinical data will be collected for each infant participant to include oxygen saturation reported by percentage. The data is collected using Nellcor/Covidien monitors

次要结局

  • Infant Length of Hospital Stay(From enrollment to the end of the infant's treatment or at 6 weeks)
  • Infant Calorie Intake(Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.)
  • Infant Weight(Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.)
  • Infant Sleep Record(Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.)
  • Caregiver Postpartum Bonding Questionnaire(Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.)
  • Caregiver Perceived Stress Scale-NICU(Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.)
  • Caregiver State-Trait Anxiety Inventory(Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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