NCT05726552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

January 24, 2023

Last Update Submit

May 25, 2026

Conditions

Outcome Measures

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).

    4 months

Secondary Outcomes (2)

  • Kidney Disease Quality of Life Scoring

    4 months

  • Cortisol level

    4 months

Study Arms (2)

Laughter Therapy group

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Laughter Therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Şule ECEVİT ALPAR, Doctorate

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Only the statistical analyst (outcome assessor) was blinded to group allocation. Participants and investigators were aware of the intervention
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 14, 2023

Study Start

April 1, 2021

Primary Completion

September 25, 2022

Study Completion

June 1, 2023

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations