- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05979012
Jazz Music and Mindfulness for Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Group Assignments
Participants will be randomized into one of three groups.
- Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation video prior to the 4-week intervention.
- Jazz Group 2 (Mindful Jazz) Group: Participants in this group will watch a video on mindful listening to jazz.
- Music Waitlist Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed. They will complete a baseline survey and a follow-up survey at four weeks. Some videos will be sent to this group after the study is completed, without tracking their usage.
Intervention
All groups will complete a baseline and 4-week follow-up survey.
Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. It is up to them if they want to listen to the daily recordings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Irvine, 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:
- Are 18+
- Live in the US
- Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed on type)
- Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale in the preceding week
- Have had pain for at least 3 months and for at least 15 days in the preceding 30 days
- Have moderate to severe anxiety based on GAD-7
Exclusion Criteria:
- Are currently using or have used prescription opioids in the past 3 months to minimize a known treatment confound and increase sample homogeneity
- Have a current cancer diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Jazz Only
Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation video prior to the 4-week intervention.
|
All groups will complete a baseline and 4-week follow-up survey. Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. The recordings will increase gradually throughout the study, starting with about 10 minutes each day in the first week and reaching 30 minutes each day in the final week. The schedule is as follows: Week 1= 10 minutes, Week 2= 15 minutes, Week 3= 20 minutes Week 4= 30 minutes. It is up to them if they want to listen to the daily recordings. |
|
Experimental: MIndfullness and Jazz
Jazz Group 2 (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.
|
All groups will complete a baseline and 4-week follow-up survey. Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.It is up to them if they want to listen to the daily recordings. |
|
No Intervention: Waitlist
Music Waitlist Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed.
They will complete a baseline survey and a follow-up survey at four weeks.
Some videos will be sent to this group after the study is completed, without tracking their usage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity portion of The Pain, Enjoyment of Life and General Activity (PEG) scale
Time Frame: 4 weeks
|
The Pain, Enjoyment of Life and General Activity (PEG) scale will be used to assess the magnitude of pain sensations experienced by participants in the past week.
Range 0-10, where higher score equals more pain.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 4 weeks
|
The PEG scale will be used to assess the magnitude of pain sensations experienced by participants in the past week.
|
4 weeks
|
|
Pain Interference
Time Frame: 4 weeks
|
The degree of pain interference in different aspects of participants' lives will be evaluated using the PEG scale.
|
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
- 3454
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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