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Active, Not Recruiting

NCT Number: NCT06829745

The Effect of Laughter Yoga Practiced After Burn Dressing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Burns Laughter Yoga Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Lütfi Kırdar Şehir Hastanesi, Istanbul, Kartal, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

The Effect of Laughter Yoga Practiced After Burn Dressing on Pain, Anxiety and Mental Well-Being Levels.

Acronym: laughteryoga

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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