Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients

Anxiety Clinical Trial

Official title:

Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05979103
• Other study ID #: #3585
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: November 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: November 2023
• Est. primary completion date: November 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

Related Conditions & MeSH terms

• Anxiety
• Chronic Pain

Intervention

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.
• 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.

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