RecruitingNot ApplicableNCT07327138

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

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.

Sponsor

Bahaa Bou Dargham

Enrollment

60 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia ALL

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

Min Age: 2 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a gentle, home-based laughter yoga program can help reduce pain and improve mood in young children with leukemia who experience steroid-related pain during chemotherapy. A parent or guardian participates alongside the child in the video-guided sessions. **You may be eligible if...** - Your child is between 2 and 10 years old - Your child has been diagnosed with acute lymphoblastic leukemia (ALL) and is currently receiving chemotherapy that includes dexamethasone (a steroid) during the maintenance phase - Your child is clinically stable and able to participate in gentle, low-intensity movements - At least one parent or guardian is available and willing to participate in the sessions at home **You may NOT be eligible if...** - Your child had major surgery in the past 2 weeks - Your child has unstable vital signs, severe heart or breathing problems, or uncontrolled seizures - Your child has a severe visual, hearing, or cognitive impairment that prevents following video instructions - Your child has physical injuries or limitations that prevent gentle movement - Your child is already in another pain management trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLaughter 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 intervention is designed to be non-invasive, low intensity, and safe for children receiving chemotherapy, and it is provided in addition to standard medical and supportive care.