Clinical trial NCT06829745: The Effect of Laughter Yoga Practiced After Burn Dressing
Official title: The Effect of Laughter Yoga Practiced After Burn Dressing on Pain, Anxiety and Mental Well-Being Levels.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Burns
Laughter Yoga
Keywords: Burns
Laughter Yoga
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Using anxiolytic and sedative drugs,
* Having a psychiatric illness,
* Patients with communication disabilities will not be included in the research.

Primary outcomes:
measure: Level of mental well-being
timeFrame: 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.
measure: Visual Analogue Scale (VAS) for Pain and Satisfaction Levels
timeFrame: 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.
measure: State-Trait Anxiety Inventory level
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Lütfi Kırdar Şehir Hastanesi
state: Kartal
city: Istanbul
country: Turkey
facility: Kartal Dr. Lütfi Kırdar Şehir Hastanesi
state: Kartal
Study officials:
affiliation: Kartal Dr. Lütfi Kırdar Şehir Hastanesi
name: fatma sahin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Morishima 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.
citation: Hayashi 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.