Skip to main content
OpenTrials
Completed

NCT Number: NCT05726552

The Effect of Laughter Therapy on Hemodialysis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laughter Therapy Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Hemodialysis Life Quality Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zonguldak Bülent Ecevit University

Zonguldak, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Laughter therapy

Other

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.

Primary outcomes

  1. Depression, Anxiety, Stress scale

    Time frame: 4 months

    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).

Secondary outcomes

  1. Kidney Disease Quality of Life Scoring

    Time frame: 4 months

    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.

  2. Cortisol level

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Collaborators

  • Marmara University

Registry information

Official study title

Effect of Laughter Therapy on Hemodialysis Patients: A Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 14, 2023
Registry last updated
May 28, 2026

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.