- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05726552
Effect of Laughter Therapy on hemodıalysıs patıents
The Effect of Laughter Therapy on Serum Cortisol, Quality of Life and Depression and Anxiety Stress Levels in Hemodialysis Patients.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zonguldak, Turkey
- Zonguldak Bulent Ecevit University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Do not prevent you from doing laughter yoga (having undergone abdominal surgery in the last three months, uncontrollable hypertension, chronic cough, incontinence, acute low back pain, acute mental disorders, consumption of antipsychotic drugs, glaucoma, hernia, epilepsy)
- History of psychiatric illness (major depression, alcohol abuse, substance abuse, schizophrenia or paranoid disorders, personality disorder, somatoform disorder)
- Standardized Mini Mental Test (SMMT) score 24>
- Not doing laughter yoga before
- Being able to use smart phone/computer/tablet and using internet applications actively
Exclusion Criteria:
- Initiation of medication that may affect serum cortisol levels
- Diagnosis of psychiatric illness during sessions
- Surgery on the abdominal region during laughter sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Laughter Therapy group
Hemodialysis patients(40) enrolled in the laughter therapy group will receive a total of 12 sessions of laughter therapy, 50 minutes, 3 days a week.
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Laughter therapy will be applied for 50 minutes, 12 sessions, 3 days a week. The therapy, which starts with the stimulation of the acupuncture points in the palm and acquaintance with hand clapping for an average of 10 minutes, continues with deep breathing and breathing exercises that include diaphragmatic breathing. The childish games section, which is played to reveal and trigger simulated laughter, is the section where laughter starts as "if" and turns into reality. The last part is the part where the group makes eye contact for no reason and for no reason, and laughs for at least 3 minutes unconditionally. In the last part, wish meditation and relaxation sessions are performed. |
NO_INTERVENTION: Control
No attempt will be made to hemodialysis patients in this group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kidney Disease Quality of Life Scoring
Time Frame: 4 months
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The Kidney Disease Quality of Life Scale (KDQOL-SF) is a scale used to evaluate the well-being and function of individuals with kidney disease and undergoing dialysis treatment.
The scale was developed by Hays et al. in the USA in 1994 (Hays et al., 1994).
The validity and reliability study in our country was carried out by Yıldırım et al. in 2007.
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4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol level
Time Frame: 4 months
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All cortisol levels before and after laughter were measured in a fully automatic Roche Cobas 8000 device using the elecsys cortisol II kit, according to the electrochemiluminescence immunoassay method in the central laboratory of a State Hospital.
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4 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, Anxiety, Stress scale
Time Frame: 4 months
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Depression Anxiety Stress Scale (DASS-21) was first developed by Lovibond (1995) as 42 items.
The adaptation of the 21-question DASS scale used in the study was made by Henry and Crawford (2005), and it was revealed that the short form could be used.
The scale, which was revised by Henry and Crawford, was adapted into Turkish by Yılmaz et al. (2017).
In this scale, there are 7 questions each to measure the dimensions of depression, anxiety and stress.
The first 7 questions on the scale are about anxiety, 7 questions between 8-14 are about depression and 7 questions between 15-21 are about stress.
The scale has a 4-point Likert-type rating of 0 "not at all suitable for me", 1 "somewhat appropriate for me", 2 "usually suitable for me", and 3 "completely suitable for me".
Cronbach Alpha value for each sub-dimension of the adapted scale; Anxiety (7 items) 0.80; It was found to be 0.81 for Depression (7 items) and 0.75 for Stress (7 items).
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4 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Şule ECEVİT ALPAR, Doctorate, Marmara University
Publications and helpful links
General Publications
- Kim J, Yun KS, Cho A, Kim DH, Lee YK, Choi MJ, & Park HC. High cortisol levels are associated with oxidative stress and mortality in maintenance hemodialysis patients. BMC nephrology, 2022; 23(1), 1-9. Ko Y, Lee ES, & Park S. Effects of laughter therapy on the stress response of married immigrant women in South Korea: A randomized controlled trial. Health Care Women Int. 2022;43(5): 518-531. 112. Ko YJ, Hyun MY. Effects of laughter therapy on pain, depression, and quality of life of elderly people with osteoarthritis. J Korean Acad Psychiatr Ment Health Nurs. 2013; 22(4): 359-67.
- Aminoff V, Sellen M, Sorliden E, Ludvigsson M, Berg M, Andersson G. Internet-Based Cognitive Behavioral Therapy for Psychological Distress Associated With the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Front Psychol. 2021 Jun 14;12:684540. doi: 10.3389/fpsyg.2021.684540. eCollection 2021.
- Eraydin C, Alpar SE. The effect of laughter therapy on nursing students' anxiety, satisfaction with life, and psychological well-being during the COVID-19 pandemic: Randomized controlled study. Adv Integr Med. 2022 Sep;9(3):173-179. doi: 10.1016/j.aimed.2022.06.006. Epub 2022 Jun 24.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZNGLDKBEUSBF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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