NCT06993272

Brief Summary

Chronic pain is a common complaint in inflammatory bowel disease (IBD). Compounding these concerns, opioid analgesics are frequently used to treat severe acute pain. An estimated 30% of chronic pain patients due to IBD report opioid use. Those who continue to use opioids can develop opioid misuse, and opioid misuse portends addiction and overdose so there is a need for better, non-addictive treatment options. Music interventions effectively reduce pain and pain-related symptomology. Meta-analytic results indicate listening to music can reduce acute and chronic pain. Music listening also decreases emotional distress from pain as well as the use of pain medication. Music interventions have demonstrated these positive effects on pain across a number of settings, including surgical, in-patient, and community settings. Importantly, due to the ubiquity of music - especially freely available online music - music interventions are easily accessible and highly scalable.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

April 18, 2025

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain, Enjoyment, General Activity Scale (PEG)

    Pain Intensity: Measure: The PEG scale will be used to assess the magnitude of pain sensations experienced by participants in the past week.

    Baseline and 4 weeks

Study Arms (4)

MIndful Jazz

EXPERIMENTAL

Participants in this group will watch an introduction to jazz appreciation and mindfulness training video, including the use of jazz for pain tolerance prior to the 4-week intervention. Participants in the Mindful Jazz Group will be informed that listening to music they are not comfortable with (i.e., jazz) can enhance long-term pain tolerance.

Behavioral: MIndful Jazz

Reggae Stereotypes

EXPERIMENTAL

Reggae Stereotype Group: Participants in this group will be told about he stereotype of reggae in making people more calm. They will listen to reggae music over the 4 weeks.

Behavioral: Reggae Stereotypes

Traditional Mindfulness

EXPERIMENTAL

Participants in this group will listen to a traditional mindfulness practice over the 4 weeks

Behavioral: Traditional Mindfulness

Pain Psychoeducation

ACTIVE COMPARATOR

Participants listen to the same playlist each week of the 4-weeks. It's an audio recording of the pain psychoeducation video they watch during training. Video: https://www.youtube.com/watch?v=azwEQXh5enA

Behavioral: Pain psychoeducation

Interventions

MIndful JazzBEHAVIORAL

Mindful Jazz Group: Participants in this group will watch an introduction to jazz appreciation and mindfulness training video, including the use of jazz for pain tolerance prior to the 4-week intervention. Participants in the Mindful Jazz Group will be informed that listening to music they are not comfortable with (i.e., jazz) can enhance long-term pain tolerance.

MIndful Jazz

Reggae Stereotype Group: Participants in this group will be told about he stereotype of reggae in making people more calm. They will listen to reggae music over the 4 weeks.

Reggae Stereotypes

Participants will listen to a traditional mindfulness practice over the 4 weeks

Traditional Mindfulness

Participants listen to an audio recording of the pain psychoeducation video they watch during training over the 4 weeks. Video: https://www.youtube.com/watch?v=azwEQXh5enA

Pain Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or older
  • Living in U.S.
  • Have a pain rating related to IBS, Crohn's, or Colitis of five or greater in average pain on a 0-10 numeric rating scale in the preceding week
  • Have had pain related to IBS, Crohn's, or Colitis for at least 3 months and for at least 15 days in the preceding 30 days
  • GAD Score (Moderate to Severe Anxiety)

You may not qualify if:

  • Are currently using or have used prescription opioids in the past 3 months
  • Have a current cancer diagnosis
  • In one of our prior music studies
  • Have formal experience with mindfulness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2025

First Posted

May 28, 2025

Study Start

April 20, 2025

Primary Completion

February 20, 2026

Study Completion

March 1, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations