IBS - Irritable Bowel SyndromeNCT06993272
Relaxation Music for Chronic Pain
A study testing MIndful Jazz, Reggae Stereotypes and Traditional Mindfulness in people with IBS - Irritable Bowel Syndrome and IBD - Inflammatory Bowel Disease, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, IBD - Inflammatory Bowel Disease
- What is being tested?
- MIndful Jazz, Reggae Stereotypes and Traditional Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine
Orange, California, 92868
About this study
Official title: 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.
- Being tested
- MIndful Jazz, Reggae Stereotypes, Traditional Mindfulness, Pain psychoeducation
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIndful JazzBehavioural
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.
Reggae StereotypesBehavioural
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.
Traditional MindfulnessBehavioural
Participants will listen to a traditional mindfulness practice over the 4 weeks
Pain psychoeducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Reggae Stereotypes |
| Traditional Mindfulness | Experimental | Participants in this group will listen to a traditional mindfulness practice over the 4 weeks Receives: 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 Receives: Behavioral: Pain psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start20 Apr 2025
- Primary completion20 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean D Young, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993272
- Sponsor's protocol ID
- 5116
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation Music for Patients With Chronic Pain From IBS, Crohn's, or Colitis
- ClinicalTrials.gov ID
- NCT06993272
- Acronym / sponsor ID
- 5116
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MIndful Jazz | Experimental | Behavioral: MIndful JazzParticipants 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. |
| Reggae Stereotypes | Experimental | Behavioral: Reggae StereotypesReggae 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. |
| Traditional Mindfulness | Experimental | Behavioral: Traditional MindfulnessParticipants in this group will listen to a traditional mindfulness practice over the 4 weeks |
| Pain Psychoeducation | Active comparator | Behavioral: Pain psychoeducationParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIndful JazzMindful 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. | Behavioural | MIndful Jazz |
| Reggae StereotypesReggae 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. | Behavioural | Reggae Stereotypes |
| Traditional MindfulnessParticipants will listen to a traditional mindfulness practice over the 4 weeks | Behavioural | Traditional Mindfulness |
| Pain psychoeducationParticipants 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 | Behavioural | Pain Psychoeducation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for IBS - Irritable Bowel Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Not yet recruiting
NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
Recruiting
Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
IBS, Ulcerative Colitis, Active
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIndful Jazz, Reggae Stereotypes and Traditional Mindfulness in people with IBS - Irritable Bowel Syndrome and IBD - Inflammatory Bowel Disease, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, Enjoyment, General Activity Scale (PEG) (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.