Back to resultsMusic Therapy Intervention to Reduce Caregiver Distress at the End of Life
Primary Purpose
Quality of Life, Stress, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Quality of Life focused on measuring Hospice, Palliative Care, Integrative Medicine, Music Therapy, Inpatient, Caregiver
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Self-identified caregiver
- English-speaking
Exclusion Criteria:
1. Unable to provide consent
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music Therapy
Arm Description
1 music therapy session, lasting approximately 45 min-1 hr
Outcomes
Primary Outcome Measures
Pearlin role overload measure (ROM)
4-item self-administered measure of caregiver stress
Secondary Outcome Measures
Linear Analogue Self-Assessment (LASA)
10-item self-report of general measures of quality of life (QOL)
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
4-item self-administered screening tool that combined two validated two-item screeners for depression and anxiety
Music Therapy Program Survey
Survey to assess satisfaction regarding the therapy service provided
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03322228
Brief Title
Music Therapy Intervention to Reduce Caregiver Distress at the End of Life
Official Title
Music Therapy Intervention to Reduce Caregiver Distress at the End of Life: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Stress, Anxiety, Depression
Keywords
Hospice, Palliative Care, Integrative Medicine, Music Therapy, Inpatient, Caregiver
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study plans to enroll 20 subjects. All subjects will receive 1 music therapy intervention lasting approximately 1 hour.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
1 music therapy session, lasting approximately 45 min-1 hr
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pearlin role overload measure (ROM)
Description
4-item self-administered measure of caregiver stress
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Linear Analogue Self-Assessment (LASA)
Description
10-item self-report of general measures of quality of life (QOL)
Time Frame
Baseline to 6 months
Title
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Description
4-item self-administered screening tool that combined two validated two-item screeners for depression and anxiety
Time Frame
Baseline to 6 months
Title
Music Therapy Program Survey
Description
Survey to assess satisfaction regarding the therapy service provided
Time Frame
Up to 72 hours after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Self-identified caregiver
English-speaking
Exclusion Criteria:
1. Unable to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Lapid, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Music Therapy Intervention to Reduce Caregiver Distress at the End of Life
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