Music Therapy for Oral Mucositis Pain in Pediatric Patients

NCT07653360 — Not applicable, Not yet recruiting, 50 participants, University of California, San Francisco

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Effect of Music Therapy on Oral Mucositis Pain in Pediatric Patients

Registry	NCT07653360
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, sequential, masking: none, supportive care
Enrollment	50 (Estimated)
Sponsor	University of California, San Francisco (Other); collaborators: Perloff Family Foundation
Conditions	Oral Mucosa Discomfort, Pediatric Cancer, Mucositis Oral
Interventions	Semi-Structured Interviews (Other)
Dates	start 2026-12-15 (estimated), primary completion 2027-09-30 (estimated), completion 2027-09-30 (estimated), first posted 2026-06-17, last updated 2026-10-15
Locations	1 site in United States

-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.

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+Detailed description

Phase 1:

Aim 1a: Explore the experiences of oral mucositis pain in pediatric patients.

Aim 1b: Explore how pediatric patients perceive the involvement of music therapy during oral mucositis pain.

Phase 1 of the study involves semi-structured interviews with parent-child dyads about the child's experiences with oral mucositis and their perceptions of music therapy while experiencing oral mucositis pain. Information obtained in Phase 1 will direct the development and design of the Interventional Phase (Phase 2) not yet enrolling.

+Arms and interventions

Arm	Type	Interventions	Description
Phase 1: Interview	Other	Other: Semi-Structured Interviews	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.

Semi-Structured Interviews (Other): Participants will be interviewed online via Zoom

+Outcome measures

Primary outcomes

Identify patterns in previous experience with music therapy [1 day]: 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.

+Eligibility

Sex: All, ages: 6 Years to 64 Years, accepts healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

+Locations (1)

Facility	City	Country	Status
University of California, San Francisco	San Francisco, California	United States

+Investigators

Wei Li Jonathan Tang, MT-BC, PhD, Principal investigator, University of California, San Francisco