Describing the Effect of Familiar Song on Arousal and Awareness for Children With Disorders of Consciousness (DoC)
NCT ID: NCT07209657
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2026-01-31
2028-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 intervention and will present the recorded music via iPad and small portable speaker.
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.
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 intervention and will present the recorded music via iPad and small portable speaker.
Interventions
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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 intervention and will present the recorded music via iPad and small portable speaker.
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 intervention and will present the recorded music via iPad and small portable speaker.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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Murdoch Childrens Research Institute
OTHER
Responsible Party
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Principal Investigators
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Janeen M Bower, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Locations
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The Royal Children's Hospital Melbourne
Parkville, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Janeen M Bower, PhD
Role: primary
Jo Rimmer, MMusThrpy
Role: backup
References
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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 8;101(6):e581-e593. doi: 10.1212/WNL.0000000000207473. Epub 2023 Jun 12.
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.
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.
Other Identifiers
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113687
Identifier Type: -
Identifier Source: org_study_id