Bariatric Surgery PateintsPhase 4NCT05927402
Effect of Laughter Therapy on Surgical Stress, Oxygen Saturation, Pain and Comfort Level
A Phase 4 study testing Laughter Therapy Based on Kolcaba Comfort Theory in people with Bariatric Surgery Pateints and Lauhgter Therapy, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Pateints, Lauhgter Therapy, Laughter Yoga
- What is being tested?
- Laughter Therapy Based on Kolcaba Comfort Theory
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2022to 1 Dec 2023
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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,
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- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Düzce University Research and Application Center
Düzce
About this study
Official title: Effect of Laughter Therapy Based on Kolcaba Comfort Theory on Surgical Stress, Oxygen Saturation, Pain and Comfort Level in Bariatric Surgery Patients
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:
- Is there a significant difference between salivary cortisol levels of patients with and without laughter yoga before surgical intervention?
- Is there a significant difference between the blood glucose levels of patients who were and were not treated with laughter yoga before surgical intervention?
- 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?
- Is there a significant difference between the oxygen saturation levels of patients with and without laughter yoga before surgical intervention?
- 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?
- 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?
Read more
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.
- Conditions
- Bariatric Surgery Pateints, Lauhgter Therapy, Laughter Yoga
- Being tested
- Laughter Therapy Based on Kolcaba Comfort Theory
- Keywords
- bariatric surgery patients, laughter therapy, laughter yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter Therapy Based on Kolcaba Comfort TheoryOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress level
with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome
Measured: before first laughter therapy application
Stress level
with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome
Measured: after sixth laughter therapy application (preop first day)
Stress level
with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome
Measured: postop first day
Pain level
with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome
Measured: before first laughter therapy application
Pain level
with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome
Measured: after sixth laughter therapy application (preop first day)
Pain level
with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome
Measured: postop first day
Comfort level
with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome
Measured: before first laughter therapy application
Comfort level
with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome
Measured: after sixth laughter therapy application (preop first day)
Comfort level
with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome
Measured: postop first day
Blood glucose level
with blood glucose meter
Measured: before first laughter therapy application
Blood glucose level
with blood glucose meter
Measured: after sixth laughter therapy application (preop first day)
Blood glucose level
with blood glucose meter
Measured: postop first day
Oxygen Saturation Level
with pulse oximetry
Measured: before first laughter therapy application
oxygen saturation level
with pulse oximetry
Measured: after sixth laughter therapy application (preop first day)
Oxygen Saturation Level
with pulse oximetry
Measured: postop first day
salivary cortisol sample
salivette cortisol
Measured: before first laughter therapy application
salivary cortisol sample
salivette cortisol
Measured: after sixth laughter therapy application (preop first day)
salivary cortisol sample
salivette cortisol
Measured: postop first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start3 Jul 2022
- Primary completion15 Sep 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery PateintsStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşah Kayserilioğlu, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927402
- Sponsor's protocol ID
- ANKARAYBU-GKAYSERILIOGLU-001
- Status last verified
- Jan 2024
- First submitted
- 22 Jun 2023
- Last updated
- 11 Jan 2024
- 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 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laughter Therapy Based on Kolcaba Comfort Theory on Surgical Stress, Oxygen Saturation, Pain and Comfort Level in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT05927402
- Acronym / sponsor ID
- ANKARAYBU-GKAYSERILIOGLU-001
- Conditions
- Bariatric Surgery Pateints, Lauhgter Therapy, Laughter Yoga
- Keywords
- bariatric surgery patients, laughter therapy, laughter yoga
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 3 Jul 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 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:
- Is there a significant difference between salivary cortisol levels of patients with and without laughter yoga before surgical intervention?
- Is there a significant difference between the blood glucose levels of patients who were and were not treated with laughter yoga before surgical intervention?
- 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?
- Is there a significant difference between the oxygen saturation levels of patients with and without laughter yoga before surgical intervention?
- 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?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
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 Therapy Based on Kolcaba Comfort TheoryThe 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. | Other | – |
Primary outcome
Stress level
Time frame: before first laughter therapy application
with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome
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
Stress level
Time frame: postop first day
with Perceived Stress Scale-14, 0-56 (min-max), higher scores mean worse outcome
Pain level
Time frame: before first laughter therapy application
with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome
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
Pain level
Time frame: postop first day
with Visual Analog Scale, 0-10 (min-max), higher scores mean worse outcome
Comfort level
Time frame: before first laughter therapy application
with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome
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
Comfort level
Time frame: postop first day
with General Comfort Questionaire, 48-192 (min-max), higher scores mean worse outcome
Blood glucose level
Time frame: before first laughter therapy application
with blood glucose meter
Blood glucose level
Time frame: after sixth laughter therapy application (preop first day)
with blood glucose meter
Blood glucose level
Time frame: postop first day
with blood glucose meter
Oxygen Saturation Level
Time frame: before first laughter therapy application
with pulse oximetry
oxygen saturation level
Time frame: after sixth laughter therapy application (preop first day)
with pulse oximetry
Oxygen Saturation Level
Time frame: postop first day
with pulse oximetry
salivary cortisol sample
Time frame: before first laughter therapy application
salivette cortisol
salivary cortisol sample
Time frame: after sixth laughter therapy application (preop first day)
salivette cortisol
salivary cortisol sample
Time frame: postop first day
salivette cortisol
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 11 Jan 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laughter Therapy Based on Kolcaba Comfort Theory in people with Bariatric Surgery Pateints and Lauhgter Therapy, run by Ankara Yildirim Beyazıt 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 15 inclusion and 11 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 11 Jan 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Stress level (time frame: before first laughter therapy application). The study lists 18 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 11 Jan 2024.