Clinical trial NCT06020079: Laughter Yoga Effect Depression, Serotonin Levels With Bariatric Surgery Patient
Official title: The Effect of Laughter Yoga on Depressıon and Serotonın Levels ın Patients Who Have Been Patıent Wıth Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Depression
Keywords: bariatric surgery
depression
laughter yoga
nursing
serotonin
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2023-08-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A Guasi-experimental Study with a Pretest-Posttest Control Group Design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this a quasi-trial model with pre and post-test control group is to determine the effect of laughter yoga on depression and serotonin levels in patients undergoing bariatric surgery.

The main question's it aims to answer are:

* Question 1: Does laughter yoga reduce the level of depression in patients undergoing bariatric surgery?
* Question 2: Does laughter yoga increase serotonin levels in patients who have undergone bariatric surgery? 158 patients who underwent bariatric surgery in the General Surgery Service of a university hospital in Malatya/Turkey and 6-24 months after the operation participated in the study. Sample size was determined using power analysis and 62 patients were sampled. 31 patients were determined as the control group and 31 patients as the experimental group. 10 sessions of laughter yoga were applied to the patients in the experimental group who agreed to participate in the study that met the criteria. No intervention was made in the control group.

Detailed description: The first stage of the data, identifying the patients, was collected by the researcher in the general surgery service of the hospital determined between February-June 2021.The patient information and blood samples, which are the second phase of the data, were collected by the researcher at the same time intervals in the nursing faculty meeting room of the designated university. In order to determine the participants to participate in the research, the participants who met the criteria were contacted by phone and an appointment was requested. Face-to-face Beck Depression Scale was applied to the patients who attended the appointment in the General Surgery service. 158 patients who got 17 points from the Beck Depression Scale were determined among the 62 patients who agreed to participate in the study, the first 31 experimental groups and the second 31 control groups. Before their hospital visit for the interview, the patients were reminded that they should be fasting for blood sample collection and they should be on a 24-hour serotonin free diet. All participants filled the Patient Information Form as a pre-test in the nursing faculty meeting room and gave blood samples for serotonin levels. Laughter yoga was applied to the experimental group twice a week, on Tuesdays and Fridays, for 2,5 months, for a total of 10 sessions (each session 50 minutes) by the researcher after obtaining a laughter yoga practice certificate. Due to the COVID-19 pandemic that started during this study period, the first and last sessions were applied face-to-face, and the other eight sessions of laughter yoga were carried out with an internet program that allows online meetings. Expert opinions from laughter yoga leaders for online applicability of laughter yoga taked. After 10 sessions were applied to the participants, the Beck Depression Scale was re-administered to the participants in the experimental group as a post-test and blood samples were taken again to check the serotonin levels. The Beck Depression Scale was re-administered 5 weeks after the pretest without any intervention in the control group, and blood samples were taken again to determine serotonin levels.

Eligibility criteria: Inclusion Criteria:

* Residing in the city where the research was conducted
* Having received a score of 17 or higher on the Beck Depression Scale
* Not receiving any psychological treatment
* Having no communication problems

Exclusion Criteria:

* Having consumed foods containing serotonin (banana, walnut, tomato, eggplant, hazelnut, peanut, avocado, pineapple, kiwi, melon, dairy products, fish, eggs) in the last 24 hours on the days of blood collection
* Having diseases that may cause physical strain and increase intra-abdominal pressure during laughter yoga (e.g., bleeding hemorrhoids, all kinds of hernia, persistent cough, severe back pain, heart diseases, high blood pressure, urinary incontinence, epilepsy, complications of late morbid obesity such as anastomotic leakage, extreme nausea-vomiting, dumping syndrome, and reflux).

Primary outcomes:
measure: Measured by the Beck Depression Scale that laughter yoga would reduce depression
timeFrame: 2,5 months
measure: It was measured by the ELISA method by experts in the laboratory environment that laughter yoga would increase serotonin levels.
timeFrame: 2,5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: inonuU
Study officials:
affiliation: thessis advisor
name: meral özkan, phD
role: PRINCIPAL_INVESTIGATOR
References: