- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05927402
Effect of Laughter Therapy on Surgical Stress, Oxygen Saturation, Pain and Comfort Level
Effect of Laughter Therapy Based on Kolcaba Comfort Theory on Surgical Stress, Oxygen Saturation, Pain and Comfort Level in Bariatric Surgery Patients
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:
- Is there a significant difference between salivary cortisol levels of patients with and without laughter yoga before surgical intervention?
- Is there a significant difference between the blood glucose levels of patients who were and were not treated with laughter yoga before surgical intervention?
- 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?
- Is there a significant difference between the oxygen saturation levels of patients with and without laughter yoga before surgical intervention?
- 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?
- 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Gülşah Kayserilioğlu
- Phone Number: 905558116989
- Email: glsh.akmangl@gmail.com
Study Contact Backup
- Name: Sema Koçaşlı
- Email: skocasli@yahoo.com.tr
Study Locations
-
-
-
Düzce, Turkey
- Düzce University Research and Application Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose level
Time Frame: before first laughter therapy application
|
with blood glucose meter
|
before first laughter therapy application
|
Blood glucose level
Time Frame: after sixth laughter therapy application (preop first day)
|
with blood glucose meter
|
after sixth laughter therapy application (preop first day)
|
Blood glucose level
Time Frame: postop first day
|
with blood glucose meter
|
postop first day
|
Oxygen Saturation Level
Time Frame: before first laughter therapy application
|
with pulse oximetry
|
before first laughter therapy application
|
oxygen saturation level
Time Frame: after sixth laughter therapy application (preop first day)
|
with pulse oximetry
|
after sixth laughter therapy application (preop first day)
|
Oxygen Saturation Level
Time Frame: postop first day
|
with pulse oximetry
|
postop first day
|
Stress level
Time Frame: before first laughter therapy application
|
with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome
|
before first laughter therapy application
|
Stress level
Time Frame: after sixth laughter therapy application (preop first day)
|
with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome
|
after sixth laughter therapy application (preop first day)
|
Stress level
Time Frame: postop first day
|
with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome
|
postop first day
|
Pain level
Time Frame: before first laughter therapy application
|
with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome
|
before first laughter therapy application
|
Pain level
Time Frame: after sixth laughter therapy application (preop first day)
|
with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome
|
after sixth laughter therapy application (preop first day)
|
Pain level
Time Frame: postop first day
|
with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome
|
postop first day
|
Comfort level
Time Frame: before first laughter therapy application
|
with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome
|
before first laughter therapy application
|
Comfort level
Time Frame: after sixth laughter therapy application (preop first day)
|
with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome
|
after sixth laughter therapy application (preop first day)
|
Comfort level
Time Frame: postop first day
|
with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome
|
postop first day
|
salivary cortisol sample
Time Frame: before first laughter therapy application
|
salivette cortisol
|
before first laughter therapy application
|
salivary cortisol sample
Time Frame: after sixth laughter therapy application (preop first day)
|
salivette cortisol
|
after sixth laughter therapy application (preop first day)
|
salivary cortisol sample
Time Frame: postop first day
|
salivette cortisol
|
postop first day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ANKARAYBU-GKAYSERILIOGLU-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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