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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03322228
Other study ID # 17-005811
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2017
Est. completion date August 31, 2020

Study information

Verified date November 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age > 18 years 2. Self-identified caregiver 3. English-speaking Exclusion Criteria: 1. Unable to provide consent

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pearlin role overload measure (ROM) 4-item self-administered measure of caregiver stress Baseline to 6 months
Secondary Linear Analogue Self-Assessment (LASA) 10-item self-report of general measures of quality of life (QOL) Baseline to 6 months
Secondary 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 Baseline to 6 months
Secondary Music Therapy Program Survey Survey to assess satisfaction regarding the therapy service provided Up to 72 hours after intervention
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