End Stage Kidney DiseaseLOL-HDNCT04098627
The Effects of Laughter Therapy on Hemodialysis on Depression
A study testing Laughter Therapy in people with End Stage Kidney Disease, run by Satellite Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Laughter Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 28 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of end stage kidney disease (ESKD) and currently undergoing hemodialysis at a Satellite Healthcare Hemodialysis Center
- Ability to understand English
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- End Stage Kidney Disease
- Being tested
- Laughter Therapy
- Keywords
- laughter, depression, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Laughter, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter TherapyBehavioural
Once weekly 30-minute long group laughter therapy session for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Once weekly 30-minute long group laughter therapy session for 8 weeks while patients are on dialysis Receives: Behavioral: Laughter Therapy |
| Usual Care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Apr 2018
- Primary completion7 May 2018
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul N Bennett, PhD, Principal investigator, Satellite Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098627
- Sponsor's protocol ID
- SIH109_LOLRCT
- Acronym
- LOL-HD
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to keep all data confidential unless requested by statutory body.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Laughter Therapy on Hemodialysis on Depression: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04098627
- Acronym / sponsor ID
- LOL-HD / SIH109_LOLRCT
- Conditions
- End Stage Kidney Disease
- Keywords
- laughter, depression, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Laughter TherapyOnce weekly 30-minute long group laughter therapy session for 8 weeks while patients are on dialysis |
| Usual Care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of end stage kidney disease (ESKD) and currently undergoing hemodialysis at a Satellite Healthcare Hemodialysis Center
- Ability to understand English
Key exclusion criteria (1 listed)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter TherapyOnce weekly 30-minute long group laughter therapy session for 8 weeks | Behavioural | Intervention |
Primary outcome
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.
4 secondary outcomes
Anxiety
Time frame: 8 weeks
Subjective Wellbeing
Time frame: 8 weeks
Patient reported outcome measures (PROMs)
Time frame: 8 weeks
Psychological Distress - Patient Health Questionnaire 4 (PHQ4)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: No. We plan to keep all data confidential unless requested by statutory body.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul N Bennett, PhD principal investigator
Satellite Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Therapy in people with End Stage Kidney Disease, run by Satellite Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.