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

NCT07209657 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Janeen M Bower, PhD · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209657 on ClinicalTrials.gov