The Effect of Laughter Yoga Practiced After Burn Dressing

NCT ID: NCT06829745

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-06

Study Completion Date

2025-07-31

Brief Summary

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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

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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

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Burns Laughter Yoga

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

When laughter yoga studies in the literature are examined, the laughter yoga practitioner is the researcher himself. Therefore, due to the nature of the application method to be used, the patients and the researcher are not considered blind. The evaluator will be considered blind in the analysis of the study.

Study Groups

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Group 1(Laughter Yoga)

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).

Group Type EXPERIMENTAL

Laughter Yoga

Intervention Type OTHER

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.

Group 2 (Clinical routine)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laughter Yoga

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Fatma Özdemir Şahin

principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fatma sahin

Role: PRINCIPAL_INVESTIGATOR

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Locations

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Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, Kartal, Turkey (Türkiye)

Site Status

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, Kartal, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 38102816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31247017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26649930 (View on PubMed)

Other Identifiers

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SBÜ-HEM-FOŞ-01

Identifier Type: -

Identifier Source: org_study_id

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