Effect of Laughter Therapy on Surgical Stress, Oxygen Saturation, Pain and Comfort Level

Laughter Yoga Clinical Trial

Official title:

Effect of Laughter Therapy Based on Kolcaba Comfort Theory on Surgical Stress, Oxygen Saturation, Pain and Comfort Level in Bariatric Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05927402
• Other study ID #: ANKARAYBU-GKAYSERILIOGLU-001
• Status: Completed
• Phase: Phase 4
• 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
• 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,

Related Conditions & MeSH terms

• Laughter Yoga

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