A Multi-center, Assessor-blinded, Randomized, Parallel Group, Superiority Trial Evaluating the Efficacy of Home-based Laughter and Fun Yoga as an Adjunct for Pain Reduction in Pediatric Oncology Patients Receiving Chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Pain Intensity on Days 5 and 6
研究概览
简要总结
The goal of this clinical trial is to learn if a home-based program that combines laughter and fun yoga can help lower pain in children receiving chemotherapy. The study focuses on children with acute lymphoblastic leukemia who experience pain during treatment with chemotherapy and steroids.
The main questions this study aims to answer are:
- Does adding laughter and fun yoga to usual care lower pain levels in children receiving chemotherapy?
- Does this program reduce the need for strong pain medicines, such as opioids?
- Does the program help improve mood, anxiety, and sleep during treatment?
Researchers will compare children who receive laughter and fun yoga plus usual care with children who receive usual care alone to see if the program works.
Participants will:
- Be randomly assigned to either the laughter and fun yoga group or the usual care group
- Take part in the study during a 6-day period after receiving their chemotherapy treatment
- Have their pain measured once each day using a child-friendly pain scale
- Have parents answer short questions about pain medicine use, mood, anxiety, and sleep
The laughter and fun yoga activities are gentle, safe, and designed to be done at home with the help of a parent. All participants will continue to receive their regular medical care throughout the study.
详细描述
This study is a multicenter, randomized, parallel-group clinical trial evaluating the effectiveness of a structured home-based laughter and fun yoga intervention as an adjunct to standard care for the management of chemotherapy-related pain in children with acute lymphoblastic leukemia.
Participants are enrolled during routine chemotherapy visits and undergo baseline assessment prior to randomization. Using a 1:1 allocation ratio, participants are assigned to either the intervention group or the control group. Randomization is performed to ensure balanced group allocation across participating study centers.
The intervention consists of a structured program delivered at home over a six-day period. It integrates gentle, age-appropriate yoga movements, breathing exercises, laughter-based activities, and guided play. The activities are designed to be non-invasive, low intensity, and safe for children undergoing chemotherapy. Parents or caregivers supervise and actively participate in the sessions to support engagement and ensure safety. The intervention is intended to complement, not replace, standard medical care.
Participants assigned to the control group receive standard care only, which includes routine pharmacological and supportive pain management according to institutional protocols at each participating center. No structured laughter or yoga activities are provided to the control group during the study period.
Outcome data are collected through brief daily assessments conducted during the intervention period. Pain is assessed daily using a validated, child-friendly pain rating scale. Additional information on pain medication use and selected psychosocial outcomes is collected through parent-reported measures. Data collection procedures are designed to minimize participant burden and integrate smoothly into routine care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2-10 years.
- •Medically diagnosed with acute lymphoblastic leukemia (ALL) and currently receiving chemotherapy that includes dexamethasone pulses during the maintenance phase.
- •Clinically stable and able to participate in gentle, low-intensity yoga movements as determined by the treating physician.
- •At least one parent or legal guardian willing and able to supervise and participate in the home-based intervention sessions.
- •Written informed consent from parent/legal guardian, with age-appropriate assent from the child.
排除标准
- •Recent major surgery (within the past 2 weeks) that may limit safe participation in gentle activity.
- •Severe uncontrolled medical conditions (unstable vital signs, decompensated cardiac or respiratory disease, uncontrolled epilepsy) that may place the child at risk during light movement or laughter.
- •Severe visual, hearing, or cognitive impairment preventing engagement with video-based instructions and exercises.
- •Physical limitations or musculoskeletal injuries that prevent participation in the intervention.
- •Any other condition that, in the judgment of the treating physician, would interfere with safe participation or adherence.
- •Currently enrolled in another interventional clinical trial for pain management.
研究组 & 干预措施
Laughter and Fun Yoga Plus Usual Care
Participants randomized to this arm will receive the Magic Box Laughter and Fun Yoga Program in addition to usual care. The intervention is a structured, home-based program delivered over six consecutive days and supported by guided videos and daily activity packages. On the hospital visit day, parents receive an introduction video, the Magic Box, and six numbered packages, along with instructions and daily follow-up arrangements. Each day, parents receive a short video guiding age-appropriate activities that combine gentle fun yoga, breathing exercises, laughter-based exercises, and playful activities using materials provided in the daily packages. Parents actively supervise and participate with the child throughout the program. The intervention concludes with a celebratory session focused on positive affirmation and engagement. All participants continue to receive standard medical and supportive pain management according to institutional protocols.
干预措施: Laughter and Fun Yoga Program (Behavioral)
Usual Care Only
Participants randomized to this arm will receive usual care only, consisting of routine pharmacological and supportive pain management according to each participating center's pediatric oncology protocols. This may include analgesic medications, such as opioids if clinically indicated, as well as general supportive measures including rest, hydration, and comfort care. No structured laughter therapy, yoga activities, or other psychosocial interventions will be provided as part of the study. All participants in this arm will continue to receive standard medical care throughout the study period.
结局指标
主要结局
Mean Pain Intensity on Days 5 and 6
时间窗: Days 5 and 6 post chemotherapy and steroid administration
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale (FPS-R), a validated, child-friendly self-report tool that uses facial expressions anchored to numerical values from 0 (no pain) to 10 (worst pain). Pain will be assessed once daily at a consistent time using a standardized parent-read script, and the child will select the face that best represents their pain at that moment. Scores will be recorded immediately after assessment. The primary endpoint is defined as the average pain score measured on Day 5 and Day 6 post chemotherapy and steroid administration, corresponding to the expected peak dexamethasone-related pain window. If only one of these two measurements is available, that value will be used as the primary outcome.
次要结局
- Daily pain trajectory (Wong-Baker FACES)(From Day 0 to Day 6 post chemotherapy and steroid administration)
- Analgesic use (opioids only)(From Day 0 to Day 6 post chemotherapy and steroid administration)
- Depression(Day 0 and Day 6)
- Anxiety(Day 0 and Day 6)
- Sleep Quality(Day 0 and Day 6)
研究者
Bahaa Bou Dargham
Lecturer of Anesthesia
Beirut Arab University