The Effect of Laughter Yoga Practiced After Burn Dressing

NCT06829745 | Active Not Recruiting DMC

• 1 other identifier: SBÜ-HEM-FOŞ-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns; Laughter Yoga

Keywords

Burns; Laughter Yoga

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

Study Arms (2)

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).

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.

Interventions

Laughter Yoga 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 1(Laughter Yoga)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (2)

Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, Kartal, Turkey (Türkiye)

Location

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, Kartal, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 38102816 BACKGROUND

• 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.

  PMID: 31247017 BACKGROUND

• 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.

  PMID: 26649930 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• fatma sahin

  Kartal Dr. Lütfi Kırdar Şehir Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 17, 2025
• Study Start: February 6, 2025
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)