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Effect of Laughter Therapy on hemodıalysıs patıents

Primary Purpose

Laughter Therapy, Depression, Anxiety, Hemodialysis

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laughter therapy
Sponsored by
Zonguldak Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Laughter Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zonguldak Bülent Ecevit University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laughter Therapy group

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 24, 2023
Last Updated
February 2, 2023
Sponsor
Zonguldak Bulent Ecevit University
Collaborators
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05726552
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 25, 2022 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zonguldak Bulent Ecevit University
Collaborators
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laughter Therapy, Depression, Anxiety, Hemodialysis, Life Quality

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laughter Therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No attempt will be made to hemodialysis patients in this group.
Intervention Type
Other
Intervention Name(s)
Laughter therapy
Intervention Description
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 Outcome Measure Information:
Title
Kidney Disease Quality of Life Scoring
Description
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
Secondary Outcome Measure Information:
Title
Cortisol level
Description
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
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şule ECEVİT ALPAR, Doctorate
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Zonguldak Bülent Ecevit University
City
Zonguldak
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
result
PubMed Identifier
34194374
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.
Results Reference
result
PubMed Identifier
35782290
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.
Results Reference
result

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Effect of Laughter Therapy on hemodıalysıs patıents

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