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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03322228
Collaborator
(none)
20
1
1
34.9
0.6

Study Details

Study Description

Brief Summary

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.

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

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This study plans to enroll 20 subjects. All subjects will receive 1 music therapy intervention lasting approximately 1 hour.This study plans to enroll 20 subjects. All subjects will receive 1 music therapy intervention lasting approximately 1 hour.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Music Therapy Intervention to Reduce Caregiver Distress at the End of Life: A Feasibility Study
Actual Study Start Date :
Oct 5, 2017
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music Therapy

1 music therapy session, lasting approximately 45 min-1 hr

Other: Music Therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Pearlin role overload measure (ROM) [Baseline to 6 months]

    4-item self-administered measure of caregiver stress

Secondary Outcome Measures

  1. Linear Analogue Self-Assessment (LASA) [Baseline to 6 months]

    10-item self-report of general measures of quality of life (QOL)

  2. Patient Health Questionnaire for Depression and Anxiety (PHQ-4) [Baseline to 6 months]

    4-item self-administered screening tool that combined two validated two-item screeners for depression and anxiety

  3. Music Therapy Program Survey [Up to 72 hours after intervention]

    Survey to assess satisfaction regarding the therapy service provided

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age > 18 years

  2. Self-identified caregiver

  3. English-speaking

Exclusion Criteria:
  1. Unable to provide consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Maria Lapid, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Maria I. Lapid, M.D., M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03322228
Other Study ID Numbers:
  • 17-005811
First Posted:
Oct 26, 2017
Last Update Posted:
Nov 24, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria I. Lapid, M.D., M.D., Mayo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2020