Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy.

Официальное название

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.

Обзор

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: 1. Does adding laughter and fun yoga to usual care lower pain levels in children receiving chemotherapy? 2. Does this program reduce the need for strong pain medicines, such as opioids? 3. 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: 1. Be randomly assigned to either the laughter and fun yoga group or the usual care group 2. Take part in the study during a 6-day period after receiving their chemotherapy treatment 3. Have their pain measured once each day using a child-friendly pain scale 4. 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.

Подробное описание

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.

The primary objective of the study is to determine whether the addition of a structured, non-pharmacological home-based intervention can lower pain intensity during chemotherapy. Secondary objectives include evaluating the potential impact of the intervention on pain medication use and overall well-being. The findings of this study may help inform supportive care strategies for children undergoing cancer treatment.

Вмешательства

• Поведенческое Laughter and Fun Yoga Program
  This intervention consists of a structured, home-based laughter and fun yoga program delivered over six consecutive days. The program combines guided video-based sessions with daily activity packages containing materials for age-appropriate playful activities. The activities include gentle fun yoga movements, breathing exercises, laughter-based exercises, guided play, and positive affirmation. Parents or caregivers supervise and actively participate with the child throughout the program. The int

Первичные конечные точки

• Mean Pain Intensity on Days 5 and 6 [Срок оценки: Days 5 and 6 post chemotherapy and steroid administration]

Вторичные конечные точки (5)

• Daily pain trajectory (Wong-Baker FACES) [Срок оценки: From Day 0 to Day 6 post chemotherapy and steroid administration]
• Analgesic use (opioids only) [Срок оценки: From Day 0 to Day 6 post chemotherapy and steroid administration]
• Depression [Срок оценки: Day 0 and Day 6]
• Anxiety [Срок оценки: Day 0 and Day 6]
• Sleep Quality [Срок оценки: Day 0 and Day 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Ливан · 1 центр

• Hammoud Hospital University Medical Center — Sidon

Идентификаторы

NCT: NCT07327138 · IRB-Jun2025-IX

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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