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Laughter Yoga Effect Depression, Serotonin Levels With Bariatric Surgery Patient

NCT ID: NCT06020079

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Depression

Keywords

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bariatric surgery depression laughter yoga nursing serotonin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A Guasi-experimental Study with a Pretest-Posttest Control Group Design.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
who had undergone bariatric surgery in the general surgery ward of the university hospital 6-24 months ago. Sample size was determined using power analysis. The analysis revealed that the sample should consist of a total of 62 patients (31 intervention, 31 control),

Study Groups

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laughter yoga group

Laughter yoga was administered to the intervention group twice a week, on Tuesdays and Fridays, for 5 weeks, in a total of 10 sessions (the duration of each session was 50 minutes). Apart from the first and last sessions, eight sessions of the laughter yoga intervention were held via an Internet program with on-line meeting option due to the COVID-19 pandemic that started in March 2019. For the feasibility of online sessions, opinions were obtained from experts who provide laughter yoga leadership training.

Group Type EXPERIMENTAL

laughter yoga

Intervention Type OTHER

According to the literature and the training received on laughter yoga, the time required for the treatment of depression is 50 minutes. The first 10 minutes includes relaxation, stretching and warm-up exercises. The next 30 minutes includes laughing exercises, and finally, the last 10 minutes includes relaxation exercises.

Steps of laughter yoga sessions:

1. Clapping hands and warm-up exercises: Participants clap their hands, fingers and palms. Then, sounds like ho-ho and ha-ha are added to the clapping exercises along with the rhythm.
2. Deep breathing exercises: Breathing exercises should be repeated 3-4 times while standing
3. Childlike games: Arms are raised, imitating the funny and clumsy behavior of a child.
4. Laughter exercises: The researcher names the exercise, explains how to do it, and the group performs the exercise together.

Dance and Relaxation

Control group

no intervation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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laughter yoga

According to the literature and the training received on laughter yoga, the time required for the treatment of depression is 50 minutes. The first 10 minutes includes relaxation, stretching and warm-up exercises. The next 30 minutes includes laughing exercises, and finally, the last 10 minutes includes relaxation exercises.

Steps of laughter yoga sessions:

1. Clapping hands and warm-up exercises: Participants clap their hands, fingers and palms. Then, sounds like ho-ho and ha-ha are added to the clapping exercises along with the rhythm.
2. Deep breathing exercises: Breathing exercises should be repeated 3-4 times while standing
3. Childlike games: Arms are raised, imitating the funny and clumsy behavior of a child.
4. Laughter exercises: The researcher names the exercise, explains how to do it, and the group performs the exercise together.

Dance and Relaxation

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role collaborator

Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Gulnaz Kizilkaya

Assistant profesör, phD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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meral özkan, phD

Role: PRINCIPAL_INVESTIGATOR

thessis advisor

Locations

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inonuU

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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http://161.9.164.68/xmlui/handle/11616/61878

national thesis center

Other Identifiers

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InonuU

Identifier Type: -

Identifier Source: org_study_id