Bariatric SurgeryNCT06020079
Laughter Yoga Effect Depression, Serotonin Levels With Bariatric Surgery Patient
A study testing laughter yoga in people with Bariatric Surgery and Depression, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Depression
- What is being tested?
- laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga on Depressıon and Serotonın Levels ın Patients Who Have Been Patıent Wıth Bariatric Surgery
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.
Read the 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.
- Conditions
- Bariatric Surgery, Depression
- Being tested
- laughter yoga
- Keywords
- bariatric surgery, depression, laughter yoga, nursing, serotonin
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter yogaOther
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:
- 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.
- Deep breathing exercises: Breathing exercises should be repeated 3-4 times while standing
- Childlike games: Arms are raised, imitating the funny and clumsy behavior of a child.
- Laughter exercises: The researcher names the exercise, explains how to do it, and the group performs the exercise together.
Dance and Relaxation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: laughter yoga |
| Control group | No intervention | no intervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Feb 2021
- Primary completion15 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A Guasi-experimental Study with a Pretest-Posttest Control Group Design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Principal investigator, Gulnaz Kizilkaya, Tokat Gaziosmanpasa University
- Investigators
- meral özkan, phD, Principal investigator, thessis advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020079
- Sponsor's protocol ID
- InonuU
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Depressıon and Serotonın Levels ın Patients Who Have Been Patıent Wıth Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06020079
- Acronym / sponsor ID
- InonuU
- Conditions
- Bariatric Surgery, Depression
- Keywords
- bariatric surgery, depression, laughter yoga, nursing, serotonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Guasi-experimental Study with a Pretest-Posttest Control Group Design.
| Arm | Type | Receives |
|---|---|---|
| laughter yoga group | Experimental | Other: laughter yogaLaughter 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. |
| Control group | No intervention | –no intervation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laughter yogaAccording 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 | Other | laughter yoga group |
Primary outcome
Measured by the Beck Depression Scale that laughter yoga would reduce depression
Time frame: 2,5 months
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.
It was measured by the ELISA method by experts in the laboratory environment that laughter yoga would increase serotonin levels.
Time frame: 2,5 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- national thesis centerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
meral özkan, phD principal investigator
thessis advisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laughter yoga in people with Bariatric Surgery and Depression, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured by the Beck Depression Scale that laughter yoga would reduce depression (time frame: 2,5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.