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Completed

NCT Number: NCT05927402

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

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.

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Key information

Conditions

Bariatric Surgery Pateints Laughter Yoga Lauhgter Therapy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Düzce University Research and Application Center

Düzce, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

Primary outcomes

  1. Stress level

    Time frame: before first laughter therapy application

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

  2. 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

  3. Stress level

    Time frame: postop first day

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

  4. Pain level

    Time frame: before first laughter therapy application

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

  5. 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

  6. Pain level

    Time frame: postop first day

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

  7. Comfort level

    Time frame: before first laughter therapy application

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

  8. 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

  9. Comfort level

    Time frame: postop first day

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

  10. Blood glucose level

    Time frame: before first laughter therapy application

    with blood glucose meter

  11. Blood glucose level

    Time frame: after sixth laughter therapy application (preop first day)

    with blood glucose meter

  12. Blood glucose level

    Time frame: postop first day

    with blood glucose meter

  13. Oxygen Saturation Level

    Time frame: before first laughter therapy application

    with pulse oximetry

  14. oxygen saturation level

    Time frame: after sixth laughter therapy application (preop first day)

    with pulse oximetry

  15. Oxygen Saturation Level

    Time frame: postop first day

    with pulse oximetry

  16. salivary cortisol sample

    Time frame: before first laughter therapy application

    salivette cortisol

  17. salivary cortisol sample

    Time frame: after sixth laughter therapy application (preop first day)

    salivette cortisol

  18. salivary cortisol sample

    Time frame: postop first day

    salivette cortisol

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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