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The Effect of Laughter Therapy on Hemodialysis Patients

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05726552
Enrollment
69
Registered
2023-02-14
Start date
2021-04-01
Completion date
2023-06-01
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Anxiety, Hemodialysis, Laughter Therapy, Life Quality

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 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.

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.

Sponsors

Zonguldak Bulent Ecevit University
Lead SponsorOTHER
Marmara University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Only the statistical analyst (outcome assessor) was blinded to group allocation. Participants and investigators were aware of the intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Depression, Anxiety, Stress scale4 monthsDescription: 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

MeasureTime frameDescription
Kidney Disease Quality of Life Scoring4 monthsThe 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.
Cortisol level4 monthsAll 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORŞule ECEVİT ALPAR, Doctorate

Marmara University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026