- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322228
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
Conditions
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:
- Age > 18 years
- Self-identified caregiver
- 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.
Helpful Links
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.
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