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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098627
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Satellite Healthcare

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.

Condition or disease Intervention/treatment Phase
End Stage Kidney Disease Behavioral: Laughter Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Statistical Analysis Blinded
Primary Purpose: Health Services Research
Official Title: The Effects of Laughter Therapy on Hemodialysis on Depression: A Pragmatic Randomized Controlled Trial
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : May 7, 2018
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Dialysis

Arm Intervention/treatment
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

No Intervention: Usual Care
Usual care



Primary Outcome Measures :
  1. Depression [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 8 weeks ]
    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.

  2. Subjective Wellbeing [ Time Frame: 8 weeks ]
    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.

  3. Patient reported outcome measures (PROMs) [ Time Frame: 8 weeks ]
    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.

  4. Psychological Distress - Patient Health Questionnaire 4 (PHQ4) [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098627


Locations
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United States, California
Satellite Healthcare
San Jose, California, United States, 95821
Sponsors and Collaborators
Satellite Healthcare
Investigators
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Principal Investigator: Paul N Bennett, PhD Satellite Healthcare
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Responsible Party: Satellite Healthcare
ClinicalTrials.gov Identifier: NCT04098627    
Other Study ID Numbers: SIH109_LOLRCT
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We plan to keep all data confidential unless requested by statutory body.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Satellite Healthcare:
laughter
depression
hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Depression
Behavioral Symptoms
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency