Effect of Laughter Yoga on Pain, Fatigue and General Well-Being in Cancer Patients and Their Caregivers: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Pain Level
研究概览
简要总结
This study aims to evaluate the effect of laughter yoga on pain, fatigue, and general well-being in cancer patients and their caregivers. Participants will be randomly assigned to either a laughter yoga intervention group or a control group. The intervention group will receive six sessions of laughter yoga over two weeks. Outcomes will be measured before and after the intervention.
详细描述
Laughter yoga is a complementary mind-body practice that combines unconditional laughter with breathing techniques. It has been shown to reduce stress, improve mood, and promote psychological and physiological well-being. This randomized controlled trial will assess the effectiveness of a 6-session laughter yoga program on reducing pain and fatigue and enhancing general well-being in cancer patients and their caregivers. Participants in the experimental group will attend three sessions per week for two weeks, each lasting approximately 30-40 minutes. Outcomes will be measured before and after the intervention using validated scales.
Pain will be assessed using the Visual Analog Scale (VAS), which measures pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
Fatigue will be measured using the Visual Analogue Scale for Fatigue (VAS-F), a validated instrument that evaluates the intensity of fatigue and its impact on daily activities.
The General Well-Being Scale is a self-report instrument used to assess an individual's overall psychological well-being.he scale includes items related to mood, emotional state, and general life satisfaction. It is typically measured using a Likert-type format, where participants rate the frequency and intensity of their feelings or experiences on a scale (e.g., from "strongly disagree" to "strongly agree").
These validated scales will be administered at baseline (before the intervention) and at the end of the intervention (after the 6 sessions) to assess changes in the primary outcomes of pain, fatigue, and general well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who volunteer to participate in the study
排除标准
- •having asthma or COPD
- •being under 18 or over 65 years of age, and having any health condition or disability that impairs communication (such as visual or hearing impairments, or neurological or psychiatric disorders).
研究组 & 干预措施
Laughter Yoga Group
Participants in this group will receive a 6-session laughter yoga program over a 2-week period. Each session includes breathing exercises, intentional laughter practices, and light physical activity. The intervention is designed to reduce stress, enhance well-being, and improve pain and fatigue levels.
干预措施: Laughter Yoga (Behavioral)
control arm
Participants in this group will not receive any behavioral intervention during the study period. They will only complete the pre- and post-assessment questionnaires at the same intervals as the experimental group, allowing for outcome comparison.
结局指标
主要结局
Change in Pain Level
时间窗: Before and one week after the 6-session laughter yoga program
Pain will be measured using the Visual Analog Scale (VAS) at baseline and one week after the final session to assess the effectiveness of the intervention.
次要结局
- Change in Fatigue Level(Before the intervention and one week after)
研究者
Birim Kiper
nurse
Çankırı Karatekin University