NCT03322228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

October 13, 2017

Last Update Submit

November 20, 2020

Conditions

Keywords

HospicePalliative CareIntegrative MedicineMusic TherapyInpatientCaregiver

Outcome Measures

Primary Outcomes (1)

  • Pearlin role overload measure (ROM)

    4-item self-administered measure of caregiver stress

    Baseline to 6 months

Secondary Outcomes (3)

  • Linear Analogue Self-Assessment (LASA)

    Baseline to 6 months

  • Patient Health Questionnaire for Depression and Anxiety (PHQ-4)

    Baseline to 6 months

  • Music Therapy Program Survey

    Up to 72 hours after intervention

Study Arms (1)

Music Therapy

EXPERIMENTAL

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

Other: Music Therapy

Interventions

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.

Music Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Self-identified caregiver
  • English-speaking

You may not qualify if:

  • \. Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Whitford KJ, Ulrich AM, Larsen BE, Phelps CM, Siska MJ, Bigelow ML, Dockter TJ, Wood C, Walton MP, Stelpflug AJ, Lapid MI. Music Therapy Intervention to Reduce Caregiver Distress at End of Life: A Feasibility Study. J Pain Symptom Manage. 2023 May;65(5):e417-e423. doi: 10.1016/j.jpainsymman.2023.01.009. Epub 2023 Jan 19.

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Maria Lapid, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study plans to enroll 20 subjects. All subjects will receive 1 music therapy intervention lasting approximately 1 hour.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 13, 2017

First Posted

October 26, 2017

Study Start

October 5, 2017

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations