CClinicalTrials.gg
CompletedNCT05726552Updated May 28, 2026

The Effect of Laughter Therapy on Hemodialysis Patients

An interventional study of Laughter therapy in Laughter Therapy, Depression, Anxiety and Hemodialysis, sponsored by Zonguldak Bulent Ecevit University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Zonguldak Bulent Ecevit University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Apr 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 April 2021 and September 2022 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.

02

Conditions studied

  • Laughter Therapy
  • Depression, Anxiety
  • Hemodialysis
  • Life Quality
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 69 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Zonguldak Bulent Ecevit University is the lead sponsor of 96 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

The inclusion criteria for the study were as follows: (1) being 18 years of age or older, (2) having received hemodialysis treatment twice a week for at least one month, (3) having a Standard Mini Mental Test score of 24 or higher, indicating adequate cognitive function, (4) having no prior experience with laughter therapy, (5) being able to use a smartphone, computer, or tablet independently or with the support of family members, and (6) voluntarily agreeing to participate in the study.

The exclusion criteria for the study are: (1) the presence of severe psychiatric disorders, (2) use of medications that may affect serum cortisol levels, (3) recent abdominal surgery, (4) uncontrolled hypertension, (5) the presence of epilepsy, (6) the presence of other acute health issues that could pose a risk during laughter therapy, (7) participation in another complementary therapy program.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • 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.

    Other: Laughter therapy

  • No intervention
    Control

    No attempt will be made to hemodialysis patients in this group.

Interventions

  • OtherLaughter therapy

    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.

06

What researchers measure

Primary outcomes

  1. Depression, Anxiety, Stress scale

    Description: 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).

    Time frame: 4 months

Secondary outcomes

  1. Kidney Disease Quality of Life Scoring

    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.

    Time frame: 4 months

  2. Cortisol level

    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.

    Time frame: 4 months

07

Study locations

1 site
  • Zonguldak Bülent Ecevit University
    Zonguldak, Turkey (Türkiye)
08

References and documents

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. PubMed 34194374 ↗
  • 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. PubMed 35782290 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05726552
Lead sponsor
Zonguldak Bulent Ecevit University
Collaborators
Marmara University
Responsible party
Canan Eraydın (Lecturer, Zonguldak Bulent Ecevit University) — Principal investigator
First posted
Feb 14, 2023
Start date
Apr 1, 2021
Primary completion
Sep 25, 2022
Completion
Jun 1, 2023
Last update
May 28, 2026

Study contacts

Şule ECEVİT ALPAR, Doctorate
study director · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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