The Effects of Laughter Therapy on Hemodialysis on Depression

NCT04098627 | Completed

• 1 other identifier: SIH109_LOLRCT
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Kidney Disease

Keywords

laughter; depression; hemodialysis

Outcome Measures

Primary Outcomes (1)

• Depression

  Change in General Anxiety Disorder Scale 2 (GAD -2) in intervention group compared to change in the usual care group. The construct is the screening measure of depression which is calculated by the sum of 2 items on a scale of 0 to 3. A score of 3 or greater for depression is considered positive for screening purposes. The higher the sore the greater the chance of depression risk and thus the worse outcome.

  8 weeks

Secondary Outcomes (4)

• Anxiety

  8 weeks

• Subjective Wellbeing

  8 weeks

• Patient reported outcome measures (PROMs)

  8 weeks

• Psychological Distress - Patient Health Questionnaire 4 (PHQ4)

  8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Laughter Therapy

Usual Care

NO INTERVENTION

Usual care

Interventions

Laughter Therapy BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment

Sponsors & Collaborators

• Satellite Healthcare: lead

Study Sites (1)

Satellite Healthcare

San Jose, California, 95821, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Laughter; Depression

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Paul N Bennett, PhD

  Satellite Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical Analysis Blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: April 1, 2018
• Primary Completion: May 7, 2018
• Study Completion: March 28, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)