Music Therapy Intervention to Reduce Caregiver Distress at the End of Life

November 20, 2020 updated by: Maria I. Lapid, M.D., Mayo Clinic

Music Therapy Intervention to Reduce Caregiver Distress at the End of Life: A Feasibility Study

This is a study to assess the feasibility and acceptability of implementing a music therapy intervention for caregivers of hospitalized patients who are referred to inpatient hospice.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Caregivers are at high risk for stress, poor quality of life (QOL), and burnout. As a patient nears death, common themes for caregivers include anxiety and emotional distress from impending death, anticipatory grief, and acceptance of loss, which negatively impact the caregiver QOL. Investigators propose to conduct a pilot project to investigate music therapy impact on caregiver distress for caregivers of imminently dying hospitalized patients referred to hospice. Upon enrollment, caregivers will be provided a music therapy intervention with legacy-building components, and will be asked to complete 3 brief questionnaires on distress and quality of life before and after the music therapy to assess their response to the intervention. The overall aim is to reduce caregiver distress and optimize QOL.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 18 years
  2. Self-identified caregiver
  3. English-speaking

Exclusion Criteria:

1. Unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Music Therapy
1 music therapy session, lasting approximately 45 min-1 hr
Music therapy is tailored to subject preference. Examples are active music-making, supportive listening, and includes opportunities for legacy building to decrease caregiver distress and promote self-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pearlin role overload measure (ROM)
Time Frame: Baseline to 6 months
4-item self-administered measure of caregiver stress
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear Analogue Self-Assessment (LASA)
Time Frame: Baseline to 6 months
10-item self-report of general measures of quality of life (QOL)
Baseline to 6 months
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Time Frame: Baseline to 6 months
4-item self-administered screening tool that combined two validated two-item screeners for depression and anxiety
Baseline to 6 months
Music Therapy Program Survey
Time Frame: Up to 72 hours after intervention
Survey to assess satisfaction regarding the therapy service provided
Up to 72 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2017

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

August 31, 2020

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (ACTUAL)

October 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-005811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Music Therapy

Subscribe