Describing the Effect of Familiar Song on Arousal and Awareness for Children With Disorders of Consciousness (DoC)

Официальное название

A Parallel Mixed Methods Investigation of a Music Interventions in Paediatric Disorders of Consciousness (DoC)

Обзор

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.

Подробное описание

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.

On 8 of these days, participants will receive either live music therapy or recorded familiar music, with the order randomised.

Consciousness will be measured before and after each session using a paediatric adaptation of the Simplified Evaluation of Consciousness Disorders (SECONDS).

The objective is to determine whether live therapist-facilitated interventions are more effective than recorded interventions in supporting consciousness recovery.

Multiple baseline case series (Component 2):

On 2 of the 10 days, participants will take part in video-recorded sessions comparing responses during live music, recorded music, and white noise.

Behavioural responses (such as gaze, facial expression, and movement) will be coded to capture subtle and immediate changes that may not last long enough to appear in pre-post measures.

This component provides a mechanistic understanding of how children respond during auditory stimulation.

Six-month follow-up assessment (Component 3):

At 6 months post-injury, participants' level of consciousness will be reassessed in person or via telehealth.

This assessment will test whether early responsiveness to music interventions or behavioural responses during sessions are linked with longer-term recovery.

Parent and caregiver interviews (Component 4):

Parents and caregivers will be invited to take part in semi-structured interviews about their observations and experiences of music therapy during their child's admission.

Data will be analysed thematically to ensure family perspectives are embedded in the design of future clinical interventions.

Expected outcomes:

This study will provide the first controlled paediatric data comparing live and recorded music therapy in DoC. It will show whether live interventions provide unique benefits, whether early responsiveness predicts recovery, and how families experience music therapy during a critical stage of hospitalisation. Results will have immediate clinical translation by guiding how music interventions are best delivered and resourced, potentially supporting faster emergence to consciousness, shorter hospital stays, and improved wellbeing for children and their families.

Вмешательства

• Поведенческое Live Music Therapy
  The recorded music interventions will consist of the presentation of commercially available recordings of participant preferred music. The songs utilised in the recorded music interventions will be the same as those presented during the live music therapy interventions, and only the presentation format will be different. The same music therapist who facilitates the live music therapy interventions will be present in the participant's room during the presentation of the recorded music interventio
• Поведенческое Recorded Music
  The recorded music interventions will consist of the presentation of commercially available recordings of participant preferred music. The songs utilised in the recorded music interventions will be the same as those presented during the live music therapy interventions, and only the presentation format will be different. The same music therapist who facilitates the live music therapy interventions will be present in the participant's room during the presentation of the recorded music interventio

Первичные конечные точки

• Pre-post intervention change in the 'Simplified Evaluation of Consciousness Disorders (SECONDs)' [Срок оценки: Days 1-2; 4-5; 6-7; 9-10, and at 6 months post-injury]

Вторичные конечные точки (1)

• Changes in the 'Music interventions in paediatric DoC observation record (MBR)' outcomes across live music, recorded music, and control noise condition [Срок оценки: Days 3 and 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• The Royal Children's Hospital Melbourne — Parkville

Публикации

• Molteni E, Canas LDS, Briand MM, Estraneo A, Font CC, Formisano R, Fufaeva E, Gosseries O, Howarth RA, Lanteri P, Licandro GI, Magee WL, Veeramuthu V, Wilson P, Yamaki T, Slomine BS; as the Special Interest Group on DoC of the International Brain Injury Association (IBIA-DoC SIG). Scoping Review on the Diagnosis, Prognosis, and Treatment of Pediatric Disorders of Consciousness. Neurology. 2023 Aug PMID 37308301
• Aubinet C, Cassol H, Bodart O, Sanz LRD, Wannez S, Martial C, Thibaut A, Martens G, Carriere M, Gosseries O, Laureys S, Chatelle C. Simplified evaluation of CONsciousness disorders (SECONDs) in individuals with severe brain injury: A validation study. Ann Phys Rehabil Med. 2021 Sep;64(5):101432. doi: 10.1016/j.rehab.2020.09.001. Epub 2021 Jul 28. PMID 32992025
• Bower J, Magee WL, Catroppa C, Baker FA. Content Validity and Inter-rater Reliability of the Music Interventions in Pediatric DoC Behavior Observation Record. J Music Ther. 2023 May 5;60(1):13-35. doi: 10.1093/jmt/thac013. PMID 36197798

Идентификаторы

NCT: NCT07209657 · 113687

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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