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NCT04280744 · ClinicalTrials.gov registry record · NA

Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care

A NA study, sponsored by University of Pittsburgh.

Completed
Registry status
NA
Development phase
38
Enrollment target

NCT04280744: Completed NA study, sponsored by University of Pittsburgh.

NCT04280744 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04280744, a NA study, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
NA
Development phase
38 participants
Enrollment target

Study Summary

Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for child and family. High levels of stress can negatively impact outcomes, yet non-pharmacological interventions to decrease stress in the PICU are severely lacking. This is a prospective, single-arm feasibility trial that will explore the feasibility and acceptability of a music therapy intervention to decrease stress in the PICU among families of children receiving invasive or noninvasive mechanical ventilation. Objectives: The aims of this study are to: 1) Assess the feasibility of implementing a music therapy intervention in the PICU among children receiving invasive or non-invasive mechanical ventilation; 2) Determine the acceptability of the music therapy intervention in the ICU among caregivers, patients, and pediatric and cardiac ICU staff; 3) Explore the variability in child and caregiver stress outcomes throughout ICU admission. Hypothesis: The music therapy intervention will be feasible, as determined by recruitment, retention, protocol adherence, and data collection rates, and will be acceptable to participants and to PICU staff. Sample: This study will recruit 20 families that include children aged 2 months - 17 years old admitted with an expected length of ICU stay greater than 72 hours. Of these 20 families, the investigators will specifically recruit 10 families whose child is admitted for a hypoxic brain injury. Eligible children are receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support settings. One primary caregiver will be enrolled along with the child admitted into the ICU.

Primary Outcome

Feasibility of participant recruitment will be determined via recruitment rate

Interventions

  • OTHER Music therapy

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2020-06-29
Est. Completion 2022-02-01
Phase NA
University of Pittsburgh

1,238 total trials

What the finished NCT04280744 record still lists

NCT04280744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Music therapy is the first listed.

NCT04280744 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04280744 about?

NCT04280744 is a clinical study titled "Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care". Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for child and family. High levels of stress can negatively impact outcomes, yet non-pharmacological interventions to decrease stress in the PICU are severely lacking. This is a prospective, single-arm feasibility ...

What is the current status of trial NCT04280744?

This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2020-06-29. Estimated completion is 2022-02-01.

What interventions are being tested in trial NCT04280744?

The interventions under investigation include: Music therapy (OTHER).

Who is sponsoring clinical trial NCT04280744?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04280744's enrollment target sits among peer trials

38 1538th of 2000 higher than 461 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04280744, the US trial registry maintained by the National Library of Medicine. NCT04280744 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.