Live Music for Critically Ill Children

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

Interventions

BEHAVIORAL

Live-music therapy

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.

Sponsors & Collaborators

• University Medical Center Groningen

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2026-03-31

Completion

2026-04-30