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

NCT05927402 | Completed Phase 4

• 1 other identifier: ANKARAYBU-GKAYSERILIOGLU-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is there a significant difference between salivary cortisol levels of patients with and without laughter yoga before surgical intervention?
2. 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. 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. 4.Is there a significant difference between the oxygen saturation levels of patients with and without laughter yoga before surgical intervention?
5. 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. 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?

Conditions

Bariatric Surgery Pateints; Lauhgter Therapy; Laughter Yoga

Keywords

bariatric surgery patients; laughter therapy; laughter yoga

Outcome Measures

Primary Outcomes (18)

• Stress level

  with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome

  before first laughter therapy application

• Stress level

  with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome

  after sixth laughter therapy application (preop first day)

• Stress level

  with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome

  postop first day

• Pain level

  with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome

  before first laughter therapy application

• Pain level

  with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome

  after sixth laughter therapy application (preop first day)

• Pain level

  with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome

  postop first day

• Comfort level

  with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome

  before first laughter therapy application

• Comfort level

  with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome

  after sixth laughter therapy application (preop first day)

• Comfort level

  with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome

  postop first day

• Blood glucose level

  with blood glucose meter

  before first laughter therapy application

• Blood glucose level

  with blood glucose meter

  after sixth laughter therapy application (preop first day)

• Blood glucose level

  with blood glucose meter

  postop first day

• Oxygen Saturation Level

  with pulse oximetry

  before first laughter therapy application

• oxygen saturation level

  with pulse oximetry

  after sixth laughter therapy application (preop first day)

• Oxygen Saturation Level

  with pulse oximetry

  postop first day

• salivary cortisol sample

  salivette cortisol

  before first laughter therapy application

• salivary cortisol sample

  salivette cortisol

  after sixth laughter therapy application (preop first day)

• salivary cortisol sample

  salivette cortisol

  postop first day

Interventions

Laughter Therapy Based on Kolcaba Comfort Theory OTHER

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Düzce University Research and Application Center

Düzce, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: July 3, 2022
• Primary Completion: September 15, 2023
• Study Completion: December 1, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)