BurnslaughteryogaNCT06829745
The Effect of Laughter Yoga Practiced After Burn Dressing
A study testing Laughter Yoga in people with Burns and Laughter Yoga, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
Trial summary
Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. Research shows a relationship between burn dressing changes and increased pain, anxiety, and stress. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burns, Laughter Yoga
- What is being tested?
- Laughter Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 Feb 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Receiving inpatient treatment in hospital due to burns,
- Between the ages of 18 and 60, (sick individuals over the age of 60 may have chronic diseases and have problems complying with commands)
- Those with moderate or large severity burns (according to the Turkish Ministry of Health, Burn Injury Treatment Algorithm (11)).
- In individuals with 2nd degree burns, the total burn width does not exceed 40%, and in those with 3rd degree burns, the total burn width does not exceed 10%,
- At least 2 days have passed since the burn injury (the inflammatory phase has passed during the wound healing process and is in the proliferation phase),
- Not in the maturation phase according to the wound healing process, No burns in the abdomen and head and neck area (due to preventing the possible negative effects of Laughter Yoga on the specified areas)
- Patients who volunteer to participate in the research will be included in the study.
Who cannot join
- Using anxiolytic and sedative drugs,
- Having a psychiatric illness,
- Patients with communication disabilities will not be included in the research.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dr. Lütfi Kırdar Şehir Hastanesi
Istanbul, Kartal
Kartal Dr. Lütfi Kırdar Şehir Hastanesi
Istanbul, Kartal
About this study
Official title: The Effect of Laughter Yoga Practiced After Burn Dressing on Pain, Anxiety and Mental Well-Being Levels.
Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. Research shows a relationship between burn dressing changes and increased pain, anxiety, and stress. It can also be said that anxiety negatively affects wound healing. This study aimed to determine the effect of Laughter Yoga, a non-drug method, on reducing or completely eliminating pain and anxiety after burn dressing and increasing the level of mental well-being. This study is planned to be conducted in a randomized manner.
Read the detailed description
The Burn Center will consist of patients receiving treatment at the Burn Clinic. Data will be obtained through the Introductory Information Form, Visual Analogue Scale (VAS), State Anxiety Scale and Warwick Edinburgh Mental Well-Being Scale. Patients who will receive burn dressing will be visited in the clinic before the dressing and will be informed about the study. Sampled individuals will be placed into intervention and control groups using a random number table created with MS Excel software. The average hospital stay of patients is three weeks. Within the scope of the study, laughter yoga will be applied 2 hours after the dressing to the patients who are treated in the burn clinic for three weeks and are included in the intervention group.
For the control group, STAII State Anxiety Scale, Visual Analog Scale (VAS) and Warwick Edinburgh Mental Well-Being Scale levels will be determined in the same periods without any application. The data obtained will be analyzed with appropriate statistical methods using the SPSS for Windows 23.0 program (Statistical Package for the Social Sciences).
- Conditions
- Burns, Laughter Yoga
- Being tested
- Laughter Yoga
- Keywords
- Burns, Laughter Yoga
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaOther
Laughter yoga is applied to the intervention group patient 2 hours after the burn dressing. It is applied every other day for 30 minutes after dressing for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1(Laughter Yoga) | Experimental | Group-1(Laughter Yoga) Data will be obtained through the Introductory Information Form, Visual Analogue Scale (VAS), State Anxiety Scale and Warwick Edinburgh Mental Well-Being Scale. Patients who will receive burn dressing will be visited in the clinic before the dressing and will be informed about the study. Sampled individuals will be placed into intervention and control groups using a random number table created with MS Excel software. The average hospital stay of patients is three weeks. Within the scope of the study, laughter yoga will be applied 2 hours after the dressing to the patients who are treated in the burn clinic for three weeks and are included in the intervention group(30 minutes). Receives: Other: Laughter Yoga |
| Group 2 (Clinical routine) | No intervention | For the control group, STAII State Anxiety Scale, Visual Analog Scale (VAS) and Warwick Edinburgh Mental Well-Being Scale levels will be determined in the same periods without any application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of mental well-being
The emergence of mental well-being in the dimension consisting of 14 positive items. Scoring of the performance is on a 5-point Likert type, where 1 = I do not agree at all, 2 = I disagree, 3 = I somewhat agree, 4 = I configure, 5 = completely structured, and a minimum of 14 and a maximum of 70 points can be obtained from the dimension.
Measured: The mental well-being scale will be used 3 times in total: before dressing, after 3 weeks of laughter yoga, and 10 days after discharge.
Visual Analogue Scale (VAS) for Pain and Satisfaction Levels
The Visual Analog Scale is a one-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. The scale starts with "no pain" and ends with "unbearable pain". High scores from the scale indicate high pain intensity. The cut-off points for pain scores taken from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain" (89). In our study, the VAS scale will be used horizontally and in cm to measure patients' pain intensity and satisfaction levels.
Measured: VAS will be taken before the laughter yoga practice. It will be taken after the laughter yoga practice. It will be repeated a total of 18 times, on sunburn dressing days, for 3 weeks.
State-Trait Anxiety Inventory level
"State Anxiety Inventory (STAI-I)" is a tool that allows measuring how an individual feels at a certain moment and situation, that is, the level of anxiety in that situation. Each item in this inventory consists of four options: 1 (Not at all), 2 (Somewhat), 3 (Quite a bit), and 4 (Completely), which determine the intensity of the emotions felt by individuals at that moment.
Measured: State-Trait Anxiety Inventory level will be taken before the laughter yoga application. It will be taken after the laughter yoga application. It will be repeated 18 times in total, on sunburn dressing days for 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start6 Feb 2025
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a prospective interventional type two-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as clinical routine (Laughter yoga), and Group-2 (Control) was designed as clinical routine.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Özdemir Şahin, Saglik Bilimleri Universitesi
- Investigators
- fatma sahin, Principal investigator, Kartal Dr. Lütfi Kırdar Şehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829745
- Sponsor's protocol ID
- SBÜ-HEM-FOŞ-01
- Acronym
- laughteryoga
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han S, Zhang L, Li Q, Wang X, Lian S. The Effects of Laughter Yoga on Perceived Stress, Positive Psychological Capital, and Exercise Capacity in Lung Cancer Chemotherapy Patients: A Pilot Randomized Trial. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231218271. doi: 10.1177/15347354231218271.
PubMed 38102816Morishima T, Miyashiro I, Inoue N, Kitasaka M, Akazawa T, Higeno A, Idota A, Sato A, Ohira T, Sakon M, Matsuura N. Effects of laughter therapy on quality of life in patients with cancer: An open-label, randomized controlled trial. PLoS One. 2019 Jun 27;14(6):e0219065. doi: 10.1371/journal.pone.0219065. eCollection 2019.
PubMed 31247017Hayashi K, Kawachi I, Ohira T, Kondo K, Shirai K, Kondo N. Laughter and Subjective Health Among Community-Dwelling Older People in Japan: Cross-Sectional Analysis of the Japan Gerontological Evaluation Study Cohort Data. J Nerv Ment Dis. 2015 Dec;203(12):934-942. doi: 10.1097/NMD.0000000000000399.
PubMed 26649930
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga Practiced After Burn Dressing on Pain, Anxiety and Mental Well-Being Levels.
- ClinicalTrials.gov ID
- NCT06829745
- Acronym / sponsor ID
- laughteryoga / SBÜ-HEM-FOŞ-01
- Conditions
- Burns, Laughter Yoga
- Keywords
- Burns, Laughter Yoga
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 Feb 2025 (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.
Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. Research shows a relationship between burn dressing changes and increased pain, anxiety, and stress. It can also be said that anxiety negatively affects wound healing. This study aimed to determine the effect of Laughter Yoga, a non-drug method, on reducing or completely eliminating pain and anxiety after burn dressing and increasing the level of mental well-being. This study is planned to be conducted in a randomized manner.
Detailed description
The Burn Center will consist of patients receiving treatment at the Burn Clinic. Data will be obtained through the Introductory Information Form, Visual Analogue Scale (VAS), State Anxiety Scale and Warwick Edinburgh Mental Well-Being Scale. Patients who will receive burn dressing will be visited in the clinic before the dressing and will be informed about the study. Sampled individuals will be placed into intervention and control groups using a random number table created with MS Excel software. The average hospital stay of patients is three weeks. Within the scope of the study, laughter yoga will be applied 2 hours after the dressing to the patients who are treated in the burn clinic for three weeks and are included in the intervention group.
For the control group, STAII State Anxiety Scale, Visual Analog Scale (VAS) and Warwick Edinburgh Mental Well-Being Scale levels will be determined in the same periods without any application. The data obtained will be analyzed with appropriate statistical methods using the SPSS for Windows 23.0 program (Statistical Package for the Social Sciences).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a prospective interventional type two-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as clinical routine (Laughter yoga), and Group-2 (Control) was designed as clinical routine.
| Arm | Type | Receives |
|---|---|---|
| Group 1(Laughter Yoga) | Experimental | Other: Laughter YogaGroup-1(Laughter Yoga) Data will be obtained through the Introductory Information Form, Visual Analogue Scale (VAS), State Anxiety Scale and Warwick Edinburgh Mental Well-Being Scale. Patients who will receive burn dressing will be visited in the clinic before the dressing and will be informed about the study. Sampled individuals will be placed into intervention and control groups using a random number table created with MS Excel software. The average hospital stay of patients is three weeks. Within the scope of the study, laughter yoga will be applied 2 hours after the dressing to the patients who are treated in the burn clinic for three weeks and are included in the intervention group(30 minutes). |
| Group 2 (Clinical routine) | No intervention | –For the control group, STAII State Anxiety Scale, Visual Analog Scale (VAS) and Warwick Edinburgh Mental Well-Being Scale levels will be determined in the same periods without any application. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Receiving inpatient treatment in hospital due to burns,
- Between the ages of 18 and 60, (sick individuals over the age of 60 may have chronic diseases and have problems complying with commands)
- Those with moderate or large severity burns (according to the Turkish Ministry of Health, Burn Injury Treatment Algorithm (11)).
- In individuals with 2nd degree burns, the total burn width does not exceed 40%, and in those with 3rd degree burns, the total burn width does not exceed 10%,
- At least 2 days have passed since the burn injury (the inflammatory phase has passed during the wound healing process and is in the proliferation phase),
Key exclusion criteria (3 listed)
- Using anxiolytic and sedative drugs,
- Having a psychiatric illness,
- Patients with communication disabilities will not be included in the research.
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 YogaLaughter yoga is applied to the intervention group patient 2 hours after the burn dressing. It is applied every other day for 30 minutes after dressing for three weeks. | Other | Group 1(Laughter Yoga) |
Primary outcome
Level of mental well-being
Time frame: The mental well-being scale will be used 3 times in total: before dressing, after 3 weeks of laughter yoga, and 10 days after discharge.
The emergence of mental well-being in the dimension consisting of 14 positive items. Scoring of the performance is on a 5-point Likert type, where 1 = I do not agree at all, 2 = I disagree, 3 = I somewhat agree, 4 = I configure, 5 = completely structured, and a minimum of 14 and a maximum of 70 points can be obtained from the dimension.
Visual Analogue Scale (VAS) for Pain and Satisfaction Levels
Time frame: VAS will be taken before the laughter yoga practice. It will be taken after the laughter yoga practice. It will be repeated a total of 18 times, on sunburn dressing days, for 3 weeks.
The Visual Analog Scale is a one-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. The scale starts with "no pain" and ends with "unbearable pain". High scores from the scale indicate high pain intensity. The cut-off points for pain scores taken from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain" (89). In our study, the VAS scale will be used horizontally and in cm to measure patients' pain intensity and satisfaction levels.
State-Trait Anxiety Inventory level
Time frame: State-Trait Anxiety Inventory level will be taken before the laughter yoga application. It will be taken after the laughter yoga application. It will be repeated 18 times in total, on sunburn dressing days for 3 weeks.
"State Anxiety Inventory (STAI-I)" is a tool that allows measuring how an individual feels at a certain moment and situation, that is, the level of anxiety in that situation. Each item in this inventory consists of four options: 1 (Not at all), 2 (Somewhat), 3 (Quite a bit), and 4 (Completely), which determine the intensity of the emotions felt by individuals at that moment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 38102816Han S, Zhang L, Li Q, Wang X, Lian S. The Effects of Laughter Yoga on Perceived Stress, Positive Psychological Capital, and Exercise Capacity in Lung Cancer Chemotherapy Patients: A Pilot Randomized Trial. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231218271. doi: 10.1177/15347354231218271.
- Background: PubMed 31247017Morishima T, Miyashiro I, Inoue N, Kitasaka M, Akazawa T, Higeno A, Idota A, Sato A, Ohira T, Sakon M, Matsuura N. Effects of laughter therapy on quality of life in patients with cancer: An open-label, randomized controlled trial. PLoS One. 2019 Jun 27;14(6):e0219065. doi: 10.1371/journal.pone.0219065. eCollection 2019.
- Background: PubMed 26649930Hayashi K, Kawachi I, Ohira T, Kondo K, Shirai K, Kondo N. Laughter and Subjective Health Among Community-Dwelling Older People in Japan: Cross-Sectional Analysis of the Japan Gerontological Evaluation Study Cohort Data. J Nerv Ment Dis. 2015 Dec;203(12):934-942. doi: 10.1097/NMD.0000000000000399.
- 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.
fatma sahin principal investigator
Kartal Dr. Lütfi Kırdar Şehir Hastanesi
2 sites 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 Burns and Laughter Yoga, run by Saglik Bilimleri Universitesi at 2 sites 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Level of mental well-being (time frame: The mental well-being scale will be used 3 times in total: before dressing, after 3 weeks of laughter yoga, and 10 days after discharge.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06829745, which also lists 3 linked publications.
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 17 Feb 2025.