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Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients

Primary Purpose

Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Listening to Reggae Music and told the stereotype
Listening to Nature Sounds
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

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

Experimental

Active Comparator

No Intervention

Arm Label

Reggae Music

Nature Sounds

Waitlist Group

Arm Description

Group 1 (Reggae): 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.

Group 2 (Nature): Participants in this group will listen to nature sounds over the 4 weeks and will not be told any stereotypes.

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 recordings will be sent to this group after the study is completed, without tracking their usage.

Outcomes

Primary Outcome Measures

GAD-7 Score
Anxiety levels will be evaluated using the General Anxiety Disorder (GAD-7) 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 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.

Full Information

First Posted
July 28, 2023
Last Updated
July 28, 2023
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05979103
Brief Title
Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients
Official Title
Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients
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
November 2023 (Anticipated)
Study Completion Date
November 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Social psychological research has demonstrated that internalized stereotypes affect people's attitudes and behaviors. Music-based interventions that rely on stereotypes might have promise for keeping participants engaged in health interventions, reducing stress, and improving wellbeing.
Detailed Description
Group Assignments Participants will be randomized into one of three groups. Group 1 (Reggae): Participants in this group will receive the stereotype and listen to the music over the 4 weeks. Group 2 (Nature): Participants in this group will listen to nature sounds over the 4 weeks. 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 recordings 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 Group 1 and 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
Anxiety

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
Reggae Music
Arm Type
Experimental
Arm Description
Group 1 (Reggae): 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.
Arm Title
Nature Sounds
Arm Type
Active Comparator
Arm Description
Group 2 (Nature): Participants in this group will listen to nature sounds over the 4 weeks and will not be told any stereotypes.
Arm Title
Waitlist Group
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 recordings will be sent to this group after the study is completed, without tracking their usage.
Intervention Type
Behavioral
Intervention Name(s)
Listening to Reggae Music and told the stereotype
Intervention Description
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. Each day, we will send them a playlist to listen to.
Intervention Type
Behavioral
Intervention Name(s)
Listening to Nature Sounds
Intervention Description
Participants in this group will NOT be told the stereotype for the audio they are listening to. They will listen to nature sounds over the 4 weeks. Each day, we will send them a playlist to listen to.
Primary Outcome Measure Information:
Title
GAD-7 Score
Description
Anxiety levels will be evaluated using the General Anxiety Disorder (GAD-7) 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 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

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

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Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients

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