An interventional study of Live Music Therapy and Recorded Music in Disorder of Consciousness and Acquired Brain Injury, sponsored by Murdoch Childrens Research Institute. Recruiting at 1 site in Australia. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Murdoch Childrens Research Institute · Not applicable, Interventional, and Treatment
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:
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.
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.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 10 is below the median of 47 across 191 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of a severe ABI, as indicated by at least one of the following:
Diagnosis of a DoC, as indicated by at least one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Live Music Therapy
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.
Behavioral: 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.
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.
Pre-post intervention change in the 'Simplified Evaluation of Consciousness Disorders (SECONDs)'
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.
Time frame: Days 1-2; 4-5; 6-7; 9-10, and at 6 months post-injury
Changes in the 'Music interventions in paediatric DoC observation record (MBR)' outcomes across live music, recorded music, and control noise condition
The Music Behavioural Response Checklist (MBR) records behavioural responses during music interventions in children with disorders of consciousness (DoC). It has two sections: (1) arousal, capturing 13 discrete movement categories, and (2) awareness, capturing 15 categories of more complex behaviours linked to minimally conscious states and emergence. The MBR was developed and validated at the Royal Children's Hospital, showing content validity and fair to substantial inter-rater reliability. It is completed from video recordings to ensure subtle and idiosyncratic behaviours are captured.
Time frame: Days 3 and 8
Plan to share: Yes — Pending extended consent from the participant's legal guardian, de-identified Individual Participant Data (IPD) will be made available for long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Start date: 60 months following results dissemination via publication End date: When the youngest study participant turns 25 years of age
Access criteria: IPD may be accessed by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access
Data sharing details ↗ · www.mcri.edu.au
Start is estimated for Sep 2026; primary completion for Nov 2028, 26 months later.
Of 89 non-industry interventional studies with no phase under Consciousness Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's planned 26 months is above that.
Counting every sponsor, half of 94 studies reached it within 19 months; a quarter within 8 and three quarters within 52.
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Murdoch Childrens Research Institute