NCT05676151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

January 4, 2023

Last Update Submit

July 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in mood

    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.

    Baseline, after music intervention approximately 20 minutes

  • Change in pain level

    A 0-10 Likert Pain scale will be used. 0 = No Pain, 10 = Worst Pain Imaginable

    Baseline, after music intervention approximately 20 minutes

Study Arms (1)

Music Therapy in Pain Rehabilitation

EXPERIMENTAL

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

Interventions

Music TherapyBEHAVIORAL

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

Music Therapy in Pain Rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- ≤ 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Christopher Sletten, PhD, LP

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 9, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations