The Effects of Laughter Therapy on Hemodialysis on Depression

NCT ID: NCT04098627

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-03-28

Brief Summary

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End stage kidney disease is associated with increased depression. Laughter is associated with improvement in depression in chronic disease. The study objective was to measure the effect of intradialytic group laughter therapy on anxiety and depression. Pragmatic randomized controlled trial conducted in 10 hemodialysis centers in Northern California. The intervention group received a once weekly 30-minute long group laughter therapy session for 8 weeks. Primary outcome was depression score as measured using the Patient Health Questionnaire.

Detailed Description

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Conditions

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End Stage Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Statistical Analysis Blinded

Study Groups

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Intervention

Once weekly 30-minute long group laughter therapy session for 8 weeks while patients are on dialysis

Group Type EXPERIMENTAL

Laughter Therapy

Intervention Type BEHAVIORAL

Once weekly 30-minute long group laughter therapy session for 8 weeks

Usual Care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laughter Therapy

Once weekly 30-minute long group laughter therapy session for 8 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of end stage kidney disease (ESKD) and currently undergoing hemodialysis at a Satellite Healthcare Hemodialysis Center
* Ability to understand English

Exclusion Criteria

* Cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Satellite Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul N Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

Satellite Healthcare

Locations

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Satellite Healthcare

San Jose, California, United States

Site Status

Countries

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United States

Other Identifiers

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SIH109_LOLRCT

Identifier Type: -

Identifier Source: org_study_id

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