Effect of Laughter Therapy on hemodıalysıs patıents

Sponsor
Zonguldak Bulent Ecevit University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05726552
Collaborator
Marmara University (Other)
80
1
2
15
5.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Laughter therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Health Services Research
Official Title:
The Effect of Laughter Therapy on Serum Cortisol, Quality of Life and Depression and Anxiety Stress Levels in Hemodialysis Patients.
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Sep 25, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Kidney Disease Quality of Life Scoring [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.

Secondary Outcome Measures

  1. Cortisol level [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.

Other Outcome Measures

  1. Depression, Anxiety, Stress scale [4 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zonguldak Bülent Ecevit University Zonguldak Turkey

Sponsors and Collaborators

  • Zonguldak Bulent Ecevit University
  • Marmara University

Investigators

  • Study Director: Şule ECEVİT ALPAR, Doctorate, Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Canan Eraydın, Lecturer, Zonguldak Bulent Ecevit University
ClinicalTrials.gov Identifier:
NCT05726552
Other Study ID Numbers:
  • ZNGLDKBEUSBF
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2023