A Parallel Mixed Methods Investigation of a Music Interventions in Paediatric Disorders of Consciousness (DoC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Pre-post intervention change in the 'Simplified Evaluation of Consciousness Disorders (SECONDs)'
研究概览
简要总结
The goal of this clinical trial is to compare the effect of live music therapy and recorded music on recovery of consciousness in children aged 1 to 18 years who have a disorder of consciousness (DoC) after a severe brain injury. Researchers also want to learn how children respond during music and noise, whether early responses to music are linked to recovery at 6 months, and how parents experience music therapy during their child's hospital stay at The Royal Children's Hospital (RCH) in Melbourne.
Participants will:
- Take part in a 10-day study period while in hospital. On 8 of the 10 days, they will receive either live or recorded familiar music in random order. Their level of consciousness will be measured before and after each session using a simple behavioural checklist. On the other 2 days, they will take part in video-recorded sessions to compare behavioural responses during live music, recorded music, and white noise. Videos will help capture small changes in movement, eye gaze, or facial expression.
- Have their level of consciousness checked again at 6 months after injury to see if early responses relate to later recovery.
Parents and caregivers will be invited to take part in an interview about their experiences and observations of music therapy with their child.
This study will help researchers understand whether live music therapy provides benefits beyond recorded music and will guide how music therapy is best used to support children and families during recovery from severe brain injury.
详细描述
A disorder of consciousness (DoC) is a common consequence of severe acquired brain injury (ABI) in children. Children may present in coma, unresponsive wakefulness, or a minimally conscious state, and the duration of DoC is strongly linked with long-term recovery. Early, well-designed interventions are important to support emergence to consciousness and improve outcomes.
Music is considered a particularly meaningful stimulus for children because it is familiar, engaging, and closely linked with memory, emotion, and development. Live music therapy may offer additional benefits because the therapist can adjust the music in real time to the child's responses, potentially extending arousal and engagement. Recorded music, however, can be delivered more widely by families or healthcare staff, and may be more scalable. Despite widespread clinical use, especially at The Royal Children's Hospital (RCH) Melbourne, the scientific evidence for music therapy with children in DoC remains limited, and most prior studies have focused on adults.
This parallel mixed-method study has been designed to build robust paediatric-specific evidence through four integrated components:
Within-subject randomised trial (Component 1):
Participants will complete a 10-day data collection period during hospital admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Given the nature of the interventions (recorded music vs live music therapy), the interventionist, participant, and parent/legal guardian cannot be masked. However, the investigator conducting the pre-post consciousness assessment (SECONDS) will be masked. The Research Assistant (RA) completes the pre-measure before the interventionist enters the room and the post-measure after the interventionist leaves, ensuring no overlap. The interventionist always carries equipment for both conditions to maintain concealment. Behavioural ratings from the video-recorded sessions will be completed with sound removed so the RA is masked to condition. Parents/caregivers are instructed not to reveal allocation; any unblinding will be logged and reported.
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a severe ABI, as indicated by at least one of the following:
- •Glasgow Coma Scale (GCS) 3-8 at admission to RCH
- •Mass pathology evident on neuroimaging
- •Expert opinion of treating consultant
- •Diagnosis of a DoC, as indicated by at least one of the following:
- •Rancho Los Amigos Scale I, II, III or IV
- •Expert opinion of treating consultant
- •Legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Interpreters will be employed as necessary.
排除标准
- •ABI not compatible with life/child expected to die
- •ABI resulting from suspected non-accidental causes, including assault/abuse
- •Diagnosed premorbid or acquired severe hearing loss
- •Inability or unwillingness of legally acceptable representative to give written informed consent
研究组 & 干预措施
Live music therapy intervention
Live music therapy sessions will be delivered by an experienced music therapist using familiar songs with guitar accompaniment. Musical elements may be adapted in real time in response to the child's behaviours to support engagement. Each session will last about 20 minutes, tailored to the child's reduced state of consciousness and to minimise overstimulation or fatigue.
干预措施: Live Music Therapy (Behavioral)
Recorded music intervention
Recorded music interventions will use commercially available recordings of the same familiar songs presented in the live sessions, with only the format differing. The same music therapist will remain present in the room and play the recordings through an iPad and portable speaker.
干预措施: Recorded Music (Behavioral)
结局指标
主要结局
Pre-post intervention change in the 'Simplified Evaluation of Consciousness Disorders (SECONDs)'
时间窗: Days 1-2; 4-5; 6-7; 9-10, and at 6 months post-injury
The Simplified Evaluation of Consciousness Disorders (SECONDS) is an 8-item behavioural scale assessing responsiveness across the spectrum of disorders of consciousness (DoC). Items progress in complexity from arousal response (1) to functional communication (8). The SECONDS is adapted from the Coma Recovery Scale-Revised but is faster to administer, making it suitable in acute paediatric settings. It has strong validity and inter-rater reliability in diagnosing prolonged DoC. For this trial, child-friendly modifications are used (e.g., age-appropriate toys, picture books, and yes/no questions) to ensure suitability for children.
次要结局
- Changes in the 'Music interventions in paediatric DoC observation record (MBR)' outcomes across live music, recorded music, and control noise condition(Days 3 and 8)