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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05979012
Other study ID # #3454
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2023
Est. completion date October 2023

Study information

Verified date July 2023
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Group Assignments Participants will be randomized into one of three groups. 1. Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation video prior to the 4-week intervention. 2. Jazz Group 2 (Mindful Jazz) Group: Participants in this group will watch a video on mindful listening to jazz. 3. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Are 18+ 2. Live in the US 3. Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed on type) 4. Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale in the preceding week 5. Have had pain for at least 3 months and for at least 15 days in the preceding 30 days 6. Have moderate to severe anxiety based on GAD-7 Exclusion Criteria: 1. Are currently using or have used prescription opioids in the past 3 months to minimize a known treatment confound and increase sample homogeneity 2. Have a current cancer diagnosis

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States University of California Irvine Irvine California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary Global Satisfaction with Treatment Participants' overall satisfaction with the treatment will be measured using the Patients' Global Impression of Change (PGIC) scale. 4 weeks
Secondary Pain Intensity The PEG scale will be used to assess the magnitude of pain sensations experienced by participants in the past week. 4 weeks
Secondary Pain Interference The degree of pain interference in different aspects of participants' lives will be evaluated using the PEG scale. 4 weeks
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