Oral Mucosa DiscomfortNCT07653360
Music Therapy for Oral Mucositis Pain in Pediatric Patients
A study testing Semi-Structured Interviews in people with Oral Mucosa Discomfort and Pediatric Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucosa Discomfort, Pediatric Cancer, Mucositis Oral
- What is being tested?
- Semi-Structured Interviews
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Jonathan Tang, MT-BC, PhD, 415-353-3327, Jonathan.Tang2@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Effect of Music Therapy on Oral Mucositis Pain in Pediatric Patients
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.
Read the 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.
- Conditions
- Oral Mucosa Discomfort, Pediatric Cancer, Mucositis Oral
- Being tested
- Semi-Structured Interviews
- Keywords
- Music Therapy
- Medical subject headings
- Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-Structured InterviewsOther
Participants will be interviewed online via Zoom
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Semi-Structured Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Dec 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucosa DiscomfortStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Phase 2 of the study will open for enrollment after Phase 1 has been completed.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Perloff Family Foundation
- Responsible party
- Sponsor
- Investigators
- Wei Li Jonathan Tang, MT-BC, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653360
- Sponsor's protocol ID
- 260818
- Other IDs
- NCI-2026-04493
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data collected may be shared with study collaborators during the course of the study.