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Recruiting NCT07327138

NCT07327138 Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy.

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Clinical Trial Summary
NCT ID NCT07327138
Status Recruiting
Phase
Sponsor Bahaa Bou Dargham
Condition Acute Lymphoblastic Leukemia ALL
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2025-10-15
Primary Completion 2026-10

Trial Parameters

Condition Acute Lymphoblastic Leukemia ALL
Sponsor Bahaa Bou Dargham
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 2 Years
Max Age 10 Years
Start Date 2025-10-15
Completion 2026-10
Interventions
Laughter and Fun Yoga Program

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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 exercis

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