Jazz Music and Mindfulness for Chronic Pain

Sponsor

University of California, Irvine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05979012

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

44.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic pain, including spinal pain and osteoarthritis, is the leading cause of years lived with disability world-wide and the costliest health condition in the U.S. today. Compounding these concerns, opioid analgesics remain the primary pharmacological treatment for chronic pain. An estimated 21-29% of chronic pain patients receiving long-term opioid therapy develop opioid misuse, and opioid misuse portends addiction and overdose. Clearly, chronic pain patients need better, non-addictive treatment options designed to reverse the downward spiral of chronic pain.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: MIndfulness Listening to Jazz Behavioral: Listening to Jazz	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Jazz Music and Mindfulness for Chronic Pain

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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.	Behavioral: Listening to Jazz 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.	Behavioral: MIndfulness Listening to Jazz 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.

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.

Behavioral: Listening to Jazz

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.

Behavioral: MIndfulness Listening to Jazz

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.

Outcome Measures

Primary Outcome Measures

Pain Self-Efficacy [4 weeks]
Pain self-efficacy, which refers to participants' confidence in their ability to manage pain, will be assessed using the Pain Self-Efficacy Questionnaire.
Global Satisfaction with Treatment [4 weeks]
Participants' overall satisfaction with the treatment will be measured using the Patients' Global Impression of Change (PGIC) scale.

Secondary Outcome Measures

Pain Intensity [4 weeks]
The PEG scale will be used to assess the magnitude of pain sensations experienced by participants in the past week.
Pain Interference [4 weeks]
The degree of pain interference in different aspects of participants' lives will be evaluated using the PEG scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Irvine	Irvine	California	United States	92868

Sponsors and Collaborators

University of California, Irvine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sean D Young, Professor, University of California, Irvine

ClinicalTrials.gov Identifier:

NCT05979012

Other Study ID Numbers:

#3454

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Aug 7, 2023