Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Listening to Reggae Music and told the stereotype; Behavioral: Listening to Nature Sounds

Detailed Description

Group Assignments

Participants will be randomized into one of three groups.

1. Group 1 (Reggae): Participants in this group will receive the stereotype and listen to the music over the 4 weeks.
2. Group 2 (Nature): Participants in this group will listen to nature sounds over the 4 weeks.
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 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • University of California Irvine
      • Contact: Dominic Ugarte, MD; Email: dugarte@hs.uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reggae Music; 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.	Behavioral: Listening to Reggae Music and told the stereotype; 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.
Active Comparator: Nature Sounds; Group 2 (Nature): Participants in this group will listen to nature sounds over the 4 weeks and will not be told any stereotypes.	Behavioral: Listening to Nature Sounds; 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.
No Intervention: Waitlist Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Satisfaction with Treatment	Participants' overall satisfaction with the treatment will be measured using the Patients' Global Impression of Change (PGIC) scale.	4 weeks
GAD-7 Score	Anxiety levels will be evaluated using the General Anxiety Disorder (GAD-7) questionnaire.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: #3585

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No