Live Music for Critically Ill Children

NCT06845787 | Not Yet Recruiting

• 1 other identifier: Ped.Music.1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale: Admission into a pediatric intensive care unit (PICU) can be a highly stressful experience, with many children demonstrating posttraumatic stress symptoms. Most patients require titration of pain and sedation medications to facilitate care, but there is increasing concern of the impact of these medications on the developing brain and increased health risks, including drug withdrawal syndrome, delirium, and impaired circadian rhythm. One potential nonpharmacologic approach to decreasing stress and improving comfort is live-performed music therapy. Among mechanically ventilated adults, music therapy decreased physiologic and psychologic responses to stress (e.g., vital signs, self-reported anxiety) and sedative use. The use of live-performed music may be more advantageous than recorded music with a critically ill population because a music therapist is trained to manipulate musical elements to facilitate the desired outcomes and can respond immediately and adequately in response to the patient's reactions. Objective: To study the effects of live-music therapy on patient comfort, and on patient and parental stress levels and parent-child interaction, use of sedato-analgesic drugs, on haemodynamics and respiration and on the occurrence of patient-ventilator synchrony. Study design: Randomised, non-blinded pilot study Study population: Children \< 5 years old and with expected mechanical ventilatory support for at least 48 hours after inclusion. Intervention: Live-music or care-as-usual. Main study parameters/endpoints: The main study endpoint is patient comfort measured with the Dutch Version of the COMFORT Behaviour (COMFORT-B) scale. Secondary endpoints include parental stress levels, changes in hemodynamic variables (heart rate, blood pressure), changes in respiratory parameters (respiration rate, oxygen saturation, pressure-rate product, pressure-time product), daily cumulative dose of benzodiazepines, alpha-2-agonists and opioids, on-demand boluses of benzodiazepines and opioids, number of asynchronous breaths, and DNA methylation of stress genes,

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• The main study endpoint is patient comfort measured with the Dutch Version of the COMFORT Behavior (COMFORT-B) scale

  The Comfort B score is used to assess patient comfort. The Comfort-B scale used in this study is a behavioral clinical scale that consists of six factors: alertness, calmness/agitation, respiratory response (or crying, used in patients with no mechanical ventilation), physical movement, muscle tone, and facial tension.(9) Each factor can be scored with values ranging between 1 and 5, generating scores between 6 and 30 points.

  Daily until PICU discharge or up to 28 days, whichever may come first

Secondary Outcomes (12)

• Parental stress levels

  Within the first 24 hours of PICU admission, and at PICU discharge or at 28 days whichever may come first

• Quantification of the degree of DNA methylation of stress-related genes.

  Within the first 24 hours of PICU admission, and at PICU discharge or at 28 days whichever may come first

• Cumulative dose of benzodiazepines, alpha-2-agonists and opioids

  Daily until PICU discharge or up to 28 days, whichever may come first

• Percentage of asynchronous breaths

  Daily until PICU discharge or up to 28 days, whichever may come first

• Heart rate

  Daily until PICU discharge or up to 28 days, whichever may come first

Study Arms (2)

Live-music therapy

EXPERIMENTAL

Behavioral: Live-music therapy

Care as usual

NO INTERVENTION

Interventions

Live-music therapy BEHAVIORAL

Children will be offered live-music therapy for 3 consecutive sessions, 30 minute sessions in which 10 to 20 minutes of music is provided by a trained music therapist in the presence of parents. In the sessions, the music therapist will make a tailored plan for each child to avoid overstimulation, which includes choosing the appropriate instrument, determining the child's behavioural state, and continuously monitoring the child (i.e., looking for signs of relaxation but also of overstimulation such as tension, crying movements, hiccups, yawning or frowning). The music therapist will collaborate with parents in constructing a program for the sessions. Parents will be actively involved in the sessions, to stimulate their role as caregiver and empower them. The contents of the live-music is thus constantly evaluated and adapted for the individual child.

Live-music therapy

Eligibility Criteria

• Age: 0 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children \< 5 years old a

You may not qualify if:

• CNeurocognitive disorder,
• Admitted post-operatively with an expected length of stay \<48 hours,
• Critical situation where end-of-life care is expected
• Being deaf or suffer from any other hearing impairment, which would not allow for the Music Intervention to be administered
• Parents are unable to understand / speak Dutch

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Martin CJ Kneyber, MD PhD FCCM

CONTACT

0031503614215; m.c.j.kneyber@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 25, 2025
• Study Start: April 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share