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

NCT07209657 | Not Yet Recruiting

• 1 other identifier: 113687
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disorder of Consciousness; Acquired Brain Injury

Keywords

music therapy; music; paediatric disorder of consciousness

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 1-2; 4-5; 6-7; 9-10, and at 6 months post-injury

Secondary Outcomes (1)

• 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

Study Arms (2)

Live music therapy intervention

EXPERIMENTAL

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 intervention

EXPERIMENTAL

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

Interventions

Live Music Therapy BEHAVIORAL

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.

Live music therapy intervention

Recorded Music BEHAVIORAL

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

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

The Royal Children's Hospital Melbourne

Parkville, Victoria, 3052, Australia

Location

Related Publications (3)

• 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.

  PMID: 37308301 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Janeen M Bower, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janeen M Bower, PhD

CONTACT

+61 418 244 312; janeen.bower@unimelb.edu.au

Jo Rimmer, MMusThrpay

CONTACT

jo.rimmer@rch.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single site, parallel mixed method incorporating a within subject design (trial).

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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

Locations

AU (1)