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NCT04400071 · ClinicalTrials.gov registry record · NA
Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 192
- Enrollment target
NCT04400071: Completed NA study, sponsored by Indiana University.
NCT04400071 is a NA study that has completed, run by Indiana University. The registered enrollment target is 192 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04400071, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 192 participants
- Enrollment target
Study Summary
Music therapy has become a standard palliative care service in many pediatric and adult hospitals; however, a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. This study builds on prior work examining the psychosocial mechanisms of action underlying an Active Music Engagement (AME) intervention, designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents, by examining its effects on biomarkers of stress and immune function. The purposes of this two group, randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute Lymphoblastic Leukemia (ALL) treatment. Specific aims are to: Aim 1. Establish whether AME lowers child and parent cortisol during ALL treatment. Aim 2. Examine cortisol as a mediator of AME effects on child and parent outcomes during ALL treatment. Aim 3 (exploratory). Examine the dose-response relationship of AME on child and parent cortisol during ALL treatment. Findings will provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function, with direct implications for the evidence-based use of music to improve health.
Primary Outcome
We will measure salivary cortisol (a steroid hormone) as a biological indicator of stress. Cortisol is one of the most frequently used biomarkers for stress and has been used in several cancer studies.
Interventions
- BEHAVIORAL Active Music Engagement
- BEHAVIORAL Audio Storybooks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2025-04-11 |
| Phase | NA |
What the finished NCT04400071 record still lists
NCT04400071 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Active Music Engagement is the first listed.
NCT04400071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04400071 about?
NCT04400071 is a clinical study titled "Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment". Music therapy has become a standard palliative care service in many pediatric and adult hospitals; however, a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. This study builds on prior work ex...
What is the current status of trial NCT04400071?
This trial is currently completed. It is a NA study. The enrollment target is 192 participants. The study started on 2020-08-07. Estimated completion is 2025-04-11.
What interventions are being tested in trial NCT04400071?
The interventions under investigation include: Active Music Engagement (BEHAVIORAL), Audio Storybooks (BEHAVIORAL).
Who is sponsoring clinical trial NCT04400071?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04400071's enrollment target sits among peer trials
192 570th of 2000 higher than 1,427 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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