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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05927402
Other study ID # ANKARAYBU-GKAYSERILIOGLU-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 3, 2022
Est. completion date December 1, 2023

Study information

Verified date January 2024
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of laughter therapy based on Kolcaba comfort theory, on surgical stress, oxygen saturation, pain and comfort level in bariatric surgery patients. The main questions it aims to answer are: 1. Is there a significant difference between salivary cortisol levels of patients with and without laughter yoga before surgical intervention? 2. Is there a significant difference between the blood glucose levels of patients who were and were not treated with laughter yoga before surgical intervention? 3. Is there a significant difference between the mean scores on the perceived stress scale of patients who were and were not treated with laughter yoga before surgical intervention? 4. Is there a significant difference between the oxygen saturation levels of patients with and without laughter yoga before surgical intervention? 5. Is there a significant difference between the mean scores on the comfort level scale of patients who were and were not treated with laughter yoga before surgical intervention? 6. Is there a significant difference between the mean scores on the pain scale of patients who were and were not treated with laughter yoga before surgical intervention? The study population will consist of patients who will apply to the general surgery clinic of Düzce University Research and Application Center between June 2023 and April 2024, who will undergo bariatric surgery and agree to participate in the study. The data collected from these patients will be analyzed. From the patients who meet the inclusion criteria and agree to participate in the study; experimental and control groups will be determined by simple randomization. They will be informed about the research (a 15-minute presentation prepared by the researcher explaining what laughter therapy is) and their verbal and written permission will be obtained. The laughter yoga will be applied to experimanetal group. Every laughter yoga practice is 45 minutes long and is planned 3 times a week for a total of 6 sessions. Control group patients will take only routine nursing care.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 1, 2023
Est. primary completion date September 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Those who can speak and understand Turkish, - Those who agreed to participate in the study, - Adult age group between 18 and 60 years old, - Those with pain intensity <2 according to the Visual Comparison Scale, - Those with time and place orientation, - Those without vision and hearing problems, - Those who are literate or have literate relatives, - Those without history of psychiatric illness, - Those without any history of psychotropic drug use and history, - Those without previous laughter yoga practice, - Those with a smartphone/computer/tablet, - Those who undergone laparoscopic sleeve gastrectomy surgery, - Those who can attend the trainings at the specified times so that cortisol is not affected by circadian rhythm, - Those who are able to comply with the collection of saliva samples, - American Society of Anesthesiologist (ASA) score I, II or III as assessed by physicians Exclusion Criteria: - Those who speak Turkish but cannot understand, - Those who are under 18 and over 60 years of age, - Those who are not willing to participate in the study, - Those diagnosed with psychiatric illness, - Those with previous laughter yoga practice, - Those with physical limitations/respiratory problems who cannot perform yoga movements, - Those who have difficulty in doing breathing exercises due to deviated septum etc, - Those who have undergone abdominal surgery in the last six months - Hypothyroidism, hyperaldosteronism, pregnancy, malignancy, congestive heart failure, psychotic disorder, chronic liver failure, uncontrolled hypertension, glaucoma, herniation, nephrotic syndrome, type 2 diabetes mellitus, Patients with a diagnosis of chronic renal failure and continuous use of medication were excluded as salivary cortisol levels may be affected, - Those with an ASA score of 4, - Those who don't undergone laparoscopic sleeve gastrectomy surgery,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Laughter Therapy Based on Kolcaba Comfort Theory
The laughter yoga will be applied to experimanetal group. Every laughter yoga practice is 45 minutes long and is planned 3 times a week for a total of 6 sessions. Control group patients will take only routine nursing care.

Locations

Country Name City State
Turkey Düzce University Research and Application Center Düzce

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stress level with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome before first laughter therapy application
Primary Stress level with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome after sixth laughter therapy application (preop first day)
Primary Stress level with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome postop first day
Primary Pain level with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome before first laughter therapy application
Primary Pain level with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome after sixth laughter therapy application (preop first day)
Primary Pain level with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome postop first day
Primary Comfort level with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome before first laughter therapy application
Primary Comfort level with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome after sixth laughter therapy application (preop first day)
Primary Comfort level with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome postop first day
Primary Blood glucose level with blood glucose meter before first laughter therapy application
Primary Blood glucose level with blood glucose meter after sixth laughter therapy application (preop first day)
Primary Blood glucose level with blood glucose meter postop first day
Primary Oxygen Saturation Level with pulse oximetry before first laughter therapy application
Primary oxygen saturation level with pulse oximetry after sixth laughter therapy application (preop first day)
Primary Oxygen Saturation Level with pulse oximetry postop first day
Primary salivary cortisol sample salivette cortisol before first laughter therapy application
Primary salivary cortisol sample salivette cortisol after sixth laughter therapy application (preop first day)
Primary salivary cortisol sample salivette cortisol postop first day
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