- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06993272
- Original Trial
Relaxation Music for Chronic Pain
Relaxation Music for Patients With Chronic Pain From IBS, Crohn's, or Colitis
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Orange, California, United States, 92868
- University of California Irvine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MIndful Jazz
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 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.
|
|
Experimental: Reggae Stereotypes
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 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.
|
|
Experimental: Traditional Mindfulness
Participants in this group will listen to a traditional mindfulness practice over the 4 weeks
|
Participants will listen to a traditional mindfulness practice over the 4 weeks
|
|
Active Comparator: Pain Psychoeducation
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain, Enjoyment, General Activity Scale (PEG)
Time Frame: Baseline and 4 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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