Skip to main content
OpenTrials
Completed

NCT Number: NCT04098627

The Effects of Laughter Therapy on Hemodialysis on Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Satellite Healthcare

San Jose, California, 95821, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laughter Therapy

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Satellite Healthcare

Other

Registry information

Official study title

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

Acronym: LOL-HD

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 23, 2019
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.