search
Back to results

Jazz Music and Mindfulness for Chronic Pain

Primary Purpose

Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIndfulness Listening to Jazz
Listening to Jazz
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California Irvine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Jazz Only

MIndfullness and Jazz

Waitlist

Arm Description

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 an introduction to jazz appreciation and mindfulness training video, including the use of jazz for pain tolerance prior to the 4-week intervention.

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.

Outcomes

Primary Outcome Measures

Pain Self-Efficacy
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
Participants' overall satisfaction with the treatment will be measured using the Patients' Global Impression of Change (PGIC) scale.

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2023
Last Updated
July 28, 2023
Sponsor
University of California, Irvine
search

1. Study Identification

Unique Protocol Identification Number
NCT05979012
Brief Title
Jazz Music and Mindfulness for Chronic Pain
Official Title
Jazz Music and Mindfulness for Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jazz Only
Arm Type
Active Comparator
Arm Description
Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation video prior to the 4-week intervention.
Arm Title
MIndfullness and Jazz
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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 Type
Behavioral
Intervention Name(s)
MIndfulness Listening to Jazz
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Listening to Jazz
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Self-Efficacy
Description
Pain self-efficacy, which refers to participants' confidence in their ability to manage pain, will be assessed using the Pain Self-Efficacy Questionnaire.
Time Frame
4 weeks
Title
Global Satisfaction with Treatment
Description
Participants' overall satisfaction with the treatment will be measured using the Patients' Global Impression of Change (PGIC) scale.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
The PEG scale will be used to assess the magnitude of pain sensations experienced by participants in the past week.
Time Frame
4 weeks
Title
Pain Interference
Description
The degree of pain interference in different aspects of participants' lives will be evaluated using the PEG scale.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Ugarte, MD
Email
dugarte@hs.uci.edu

12. IPD Sharing Statement

Learn more about this trial

Jazz Music and Mindfulness for Chronic Pain

We'll reach out to this number within 24 hrs