Brief Summary

A randomized within-subject crossover trial to compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

171

participants targeted

Target at P75+ for not_applicable

Timeline

12mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.1 years study duration

Study Progress76%

Mar 2023May 2027

First Submitted

Initial submission to the registry

September 12, 2022

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed

6 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2027

Expected

25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

September 12, 2022

Last Update Submit

January 16, 2026

Conditions

Critical Illness

Keywords

mechanical ventilationpainstressanxiety

Outcome Measures

Primary Outcomes (6)

Change in cortisol pre-post condition
Percent change in saliva-based cortisol level, ng/ml. Reported as median change per condition and included as continuous outcome in linear regression.
Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days
Change in Interleukin-6 (IL6) pre-post condition
Percent change in saliva-based IL6 level, pg/ml. Reported as median change per condition and included as continuous outcome in linear regression.
Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days
High Frequency (HF) Heart Rate Variability
Trajectory of HF, a biomarker of sympathetic nervous activity. Reported as median value per condition and included as continuous outcome in linear regression.
1 hour prior through 2 hours post each condition, up to 3 days
Low Frequency (LF) Heart Rate Variability
Trajectory of LF, a biomarker of parasympathetic nervous activity. Reported as median value per condition and included as continuous outcome in linear regression.
1 hour prior through 2 hours post each condition, up to 3 days
HF to LF ration (HF/LF) Heart Rate Variability
Trajectory of HF/LF ratio, a biomarker of autonomic nervous system balance. Reported as median value per condition and included as continuous outcome in linear regression.
1 hour prior through 2 hours post each condition, up to 3 days
Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability
Trajectory of SDNN, a biomarker of parasympathetic and sympathetic modulation
1 hour prior through 2 hours post each condition, up to 3 days

Secondary Outcomes (3)

Acceptability
Interviews conducted within 1 month of completing primary data collection
Change in Visual Analogue Scale of Anxiety
Change <30 min. pre-post each condition for up to 3 days
Change in Face Legs Activity Consolability and Crying (FLACC)
Change <30 min. pre-post each condition for up to 3 days