NCT07653360

Brief Summary

This mixed-methods pilot study will examine the effect of music therapy on oral mucositis pain in pediatric oncology patients. Oral mucositis, characterized by painful ulcerative lesions in the mouth, is a common side effect of high-dose chemotherapy and hematopoietic stem cell or bone marrow transplantation. Despite its high prevalence and impact on quality of life, effective pain management strategies for pediatric oral mucositis remain limited and often rely heavily on medications that may cause significant side effects or provide insufficient relief. Music therapy may offer a promising non-pharmacologic adjunct for reducing pain, yet no studies to date have specifically evaluated its use for oral mucositis pain in pediatric patients.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

June 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

Music Therapy

Outcome Measures

Primary Outcomes (1)

  • Identify patterns in previous experience with music therapy

    Semi-structured interviews will be audio/video-recorded and transcribed using Zoom's built-in transcription function. Finalized transcripts will be analyzed using reflexive thematic analysis, a qualitative method for identifying and interpreting patterns within the data.

    1 day

Study Arms (1)

Phase 1: Interview

OTHER

Participants will consist of parent-child dyads and will take part in an interview conducted online (over Zoom) about the child's experiences with oral mucositis and perceptions of music therapy while experiencing oral mucositis pain. The interview is expected to last up to 1 hour.

Other: Semi-Structured Interviews

Interventions

Participants will be interviewed online via Zoom

Phase 1: Interview

Eligibility Criteria

Age6 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Phase 1
  • Child ages 6-18 years old
  • Child has received music therapy and experienced oral mucositis
  • Parent/guardian 18 years and older
  • Able to communicate in English

You may not qualify if:

  • Phase 1
  • Diagnosis of a developmental disorder that would prevent engagement in the active music-making or passive music-listening intervention or completion of study measures.
  • Significant pre-existing hearing loss or impairment that would interfere with participation in the interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

NeoplasmsStomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Wei Li Jonathan Tang, MT-BC, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Tang, MT-BC, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Phase 2 of the study will open for enrollment after Phase 1 has been completed.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified data collected may be shared with study collaborators during the course of the study.

Locations