Laughter Yoga Effect Depression, Serotonin Levels With Bariatric Surgery Patient

NCT06020079 | Completed

• 1 other identifier: InonuU
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery; Depression

Keywords

bariatric surgery; depression; laughter yoga; nursing; serotonin

Outcome Measures

Primary Outcomes (2)

• Measured by the Beck Depression Scale that laughter yoga would reduce depression

  The scale was developed by Beck et al. in 1961. Hisli conducted the Turkish validity and reliability studies of the scale in 1989 . The scale consists of 21 items assessing the symptoms that develop during depression. While the lowest score of the scale is 0, the highest score is 63. Scores between 5 and 9 indicate normal depression; scores between 10-18 indicate mild-moderate depression; scores between 19-29 indicate moderate-severe depression; and scores between 30-63 indicate severe depression. High scores indicate higher levels of depression. The cut-off point of the scale is 17. The reliability analysis of the scale showed that the Cronbach's alpha coefficient is 0.80. In our study, the pre-test Cronbach α of the Beck Depression Scale was calculated as 0.628, while the post-test Cronbach α was calculated as 0.841.

  2,5 months

• It was measured by the ELISA method by experts in the laboratory environment that laughter yoga would increase serotonin levels.

  Before taking blood from the patients, they were asked whether they fasted and followed a 24-hour serotonin-restricted diet. Approximately 6 ml of venous blood samples were taken from the participants with 10 ml injectors and placed into yellow- and red-capped blood collection tubes. The blood samples were centrifuged in the laboratory of the physiology department of the medical faculty of a university. The serum part of the centrifuged blood was placed in godets and kept in the -45 degree-refrigerators until all the blood was collected. Labels containing the patients' names, surnames and dates were attached to the godets. All frozen serums and kits were then allowed to reach room temperature for 15 minutes and processed using the ELISA method. DRG (serotonin fast elisa EIA-5061) brand kits were worked on in accordance with the package insert. The detection range of the kits was 10.2-2500 ng/ml and the sensitivity was 6.2 ng/ml.

  2,5 months

Study Arms (2)

laughter yoga group

EXPERIMENTAL

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.

Other: laughter yoga

Control group

NO INTERVENTION

no intervation

Interventions

laughter yoga 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

laughter yoga group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead
• Inonu University: collaborator

Study Sites (1)

inonuU

Malatya, 44280, Turkey (Türkiye)

Location

Related Links

• national thesis center

MeSH Terms

Conditions

Depression

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• meral özkan, phD

  thessis advisor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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),
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant profesör, phD

Model Details: A Guasi-experimental Study with a Pretest-Posttest Control Group Design.

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 31, 2023
• Study Start: February 1, 2021
• Primary Completion: April 15, 2021
• Study Completion: June 30, 2021
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)