Study of Music Therapy in Pain Rehabilitation Programs

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05676151

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to measure changes in mood, symptom burden, pain level, and stress scores in patients before and after a 20-minute music therapy intervention.

Condition or Disease	Intervention/Treatment	Phase
Music Therapy	Behavioral: Music Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

How Efficient is Music Therapy as a Distraction Technique in the Pain Rehabilitation Program Patients

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music Therapy in Pain Rehabilitation Subjects undergoing care at the Mayo Clinic Florida Pain Rehabilitation Center (PRC) to address pain will receive a 20-minute music therapy intervention	Behavioral: Music Therapy 20-minute music-therapy-informed interventions (musical bingo, songwriting, lyric scramble) guided by a music therapist

Arm

Intervention/Treatment

Experimental: Music Therapy in Pain Rehabilitation

Subjects undergoing care at the Mayo Clinic Florida Pain Rehabilitation Center (PRC) to address pain will receive a 20-minute music therapy intervention

Behavioral: Music Therapy

20-minute music-therapy-informed interventions (musical bingo, songwriting, lyric scramble) guided by a music therapist

Outcome Measures

Primary Outcome Measures

Change in mood [Baseline, after music intervention approximately 20 minutes]
We will use the NCCN distress thermometer before and after the creative work intervention to assess distress. For those patients who indicate high feelings of depression, their mood would be dealt with in accordance with clinic practice. The Distress Thermometer measures distress on a 0 to 10 scale. To report your distress, circle the number that matches your level of distress in the past week. The Problem List includes problems from 5 areas of life: practical, family, emotional, spiritual/religious, and physical problems. The higher the score the more distress experienced in that domain.
Change in pain level [Baseline, after music intervention approximately 20 minutes]
A 0-10 Likert Pain scale will be used. 0 = No Pain, 10 = Worst Pain Imaginable

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 18 years of age
Patients that are enrolled in the Pain Rehabilitation Center, Mayo Florida

Exclusion Criteria:

≤ 18 years of age.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Christopher Sletten, PhD, LP, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Christopher D. Sletten, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05676151

Other Study ID Numbers:

22-003694

First Posted:

Jan 9, 2023

Last Update Posted:

Jan 9, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 9, 2023