Clinical trial NCT05726552: Effect of Laughter Therapy on hemodıalysıs patıents
Official title: The Effect of Laughter Therapy on Serum Cortisol, Quality of Life and Depression and Anxiety Stress Levels in Hemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laughter Therapy
Depression, Anxiety
Hemodialysis
Life Quality
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2023-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Internet-based behavioral therapy applications made during the quarantine and isolation period during the pandemic process, and the application of laughter therapy, which is a group-oriented technique that increases the feeling of togetherness and happiness, can be used as an online method to reach large masses. However, since there are a limited number of studies in the literature on online laughter therapy in patients and not all sessions are online in the study, it was thought that more and methodological studies are needed to confirm the effectiveness of the therapy on the applicability of the online platform. Therefore, this study was conducted to evaluate the blood cortisol levels, depression, anxiety, stress levels and quality of life of laughter therapy in hemodialysis patients.

Detailed description: In this research, laughter therapy applied to hemodialysis patients; This is an experimental design with pretest and posttest control groups in order to examine the effects on serum cortisol levels, depression, anxiety, stress levels and quality of life. The study will be conducted between March 2023 and June 2023 on 80 patients who are receiving hemodialysis treatment in two Dialysis Centers in Zonguldak city center and meet the inclusion criteria. Introductory information form, Depression Anxiety and Stress Scale, Kidney Disease Quality of Life Form will be used in the study and blood samples will be taken from the patients for cortisol. Laughter therapy will be applied three days a week, for a total of 12 sessions for 4 weeks.

Eligibility criteria: 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

Primary outcomes:
measure: Kidney Disease Quality of Life Scoring
timeFrame: 4 months
Secondary outcomes:
measure: Cortisol level
timeFrame: 4 months
Other outcomes:
measure: Depression, Anxiety, Stress scale
timeFrame: 4 months
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
Study officials:
affiliation: Marmara University
name: Şule ECEVİT ALPAR, Doctorate
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.