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Clinical Trials/NCT02328573
NCT02328573RecruitingNot Applicable

The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers

Icahn School of Medicine at Mount Sinai1 site in 1 country80 target enrollmentStarted: April 4, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
80
Locations
1
Primary Endpoint
Change in mood and quality of life as indicated through saliva (cortisol and melatonin sampling)

Study Overview

Brief Summary

The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care

Detailed Description

The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care.

All enrolled participants will be assessed on their mood, past music experience and music genre preference (music therapy assessment). They will complete the abridged Beck (BDI-2-fastscreen) questionnaire, the stoke and aphasia quality of life scale; a Likert which measures distress; the Western Aphasia Battery (WAB); the NIH Stroke Scale (SS); the Figely compassion scale; and the driving scene test (Stern and White); and the Rankin. In additional we will take saliva samples from all participants to measure hormone levels.

Participants can attend zoom or live.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Stroke victim, regardless of level of stroke

Exclusion Criteria

  • Not provided

Arms & Interventions

Communal singing

Experimental

Participants in the study group will join the choir and participate in a weekly hour rehearsal for six months and will be assessed for aphasia, mood, and quality of life outcomes

Intervention: Communal singing (Behavioral)

Control

No Intervention

The control group will not participate in the choir for the first six months. At the end of the six months study period, all participants will be evaluated again for changes in aphasia, language, mood and quality of life

Outcomes

Primary Outcomes

Change in mood and quality of life as indicated through saliva (cortisol and melatonin sampling)

Time Frame: 6 months

Cortisol and melatonin sampling will be conducted at baseline and at 6 months

Secondary Outcomes

  • Change in language aphasia outcome improvement(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joanne Loewy

Associate Clinical Professor, Family Medicine & Community Health

Icahn School of Medicine at Mount Sinai

Study Sites (1)

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