The Effects of Laughter Therapy on Hemodialysis on Depression (LOL-HD)

The Effects of Laughter Therapy on Hemodialysis on Depression: A Pragmatic Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Behavioral: Laughter Therapy

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95821
      • Satellite Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual care
Experimental: Intervention; Once weekly 30-minute long group laughter therapy session for 8 weeks while patients are on dialysis	Behavioral: Laughter Therapy; Once weekly 30-minute long group laughter therapy session for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Change in the anxiety subscale of the Patient Health Questionnaire 4 (PHQ4) in intervention group compared to change in the usual care group.The construct is the screening measure of anxiety which is calculated by the sum of 2 items on a scale of 0 to 3. A score of 3 or greater for anxiety is considered positive for screening purposes. The higher the sore the greater the chance of anxiety risk and thus the worse outcome.	8 weeks
Subjective Wellbeing	Change in Subjective Wellbeing using the 7 item Personal Wellbeing Index (PWI) in the intervention group compared to change in the usual care group. Subjective wellbeing measures the construct of long term happiness. The Personal Wellbeing Index (PWI) is a 7 item validated scale that rates satisfaction with life in seven domains: standard of living, health, achievements in life, relationships, safety, community and future security, on an 11-point scale. The higher the rating the better the outcome. Measures are individually scored and cumulatively scored.	8 weeks
Patient reported outcome measures (PROMs)	Change in PROMS using the 6 item London Evaluation of Illness (LEVIL) in the intervention group compared to change in the usual care group. LEVIL is a 6 item visual analogue scale (VAS) developed and used in hemodialysis patients that measures general wellbeing (GWB), pain, sleep, breathing, energy, and appetite. The anchors for GWB, sleep and appetite were "very poor"-"excellent," for pain and breathing "extreme"-"no problem" and for energy "extremely fatigued"-"full of energy." For each domain the VAS allowed free selection of status along a line from worst (0) to best (100). Measures are individually scored and cumulatively scored.	8 weeks
Psychological Distress - Patient Health Questionnaire 4 (PHQ4)	Change in Psychological Distress, as measured by the Patient Health Questionnaire 4 (PHQ4), in intervention group compared to change in the usual care group. The construct is the screening measure of psychological distress which is calculated by the sum of 4 items on a scale of 0 to 3. A score of 0 to 2 is no distress, 3-5 is mild distress, 6-8 is moderate distress and 9-12 is severe distress. The higher the sore the greater the psychological distress and thus the worse outcome.	8 weeks

Collaborators and Investigators

• Sponsor: Satellite Healthcare
• Investigators: Principal Investigator: Paul N Bennett, PhD, Satellite Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): May 7, 2018
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: depression; hemodialysis; laughter
• Additional Relevant MeSH Terms: Behavioral Symptoms; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Depression; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: SIH109_LOLRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We plan to keep all data confidential unless requested by statutory body.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No