Laughter and fun yoga to ease chemotherapy pain in children
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.
This tests whether a home-based program of laughter and kid-friendly yoga can lower pain in children aged 2–10 who are receiving chemotherapy for acute lymphoblastic leukemia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 10 Years |
| Sex | All |
| Sponsor | Beirut Arab University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Sidon) |
| Trial ID | NCT07327138 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, parallel-group trial comparing a six-day home-based program of laughter activities and age-appropriate gentle yoga plus usual care to usual care alone for children with ALL. Participants are enrolled at routine chemotherapy visits, randomized 1:1, and parents or caregivers supervise daily sessions at home. The intervention combines gentle movement, breathing exercises, laughter-based activities, and guided play and is intended to complement standard medical care. Outcome data, including brief daily pain and wellbeing assessments, are collected during the intervention period to compare groups.
Who should consider this trial
Good fit: Children aged 2–10 with a medical diagnosis of acute lymphoblastic leukemia who are receiving maintenance-phase chemotherapy including dexamethasone pulses, are clinically stable, and have a parent or guardian able to supervise the home sessions are ideal candidates.
Not a fit: Children who are medically unstable, have had recent major surgery, have uncontrolled serious medical conditions, or have severe sensory or cognitive impairments that prevent engagement with video-guided activities are unlikely to benefit from the program.
Why it matters
Potential benefit: If successful, the program could lower chemotherapy-related pain in children, reduce reliance on strong pain medicines, and improve mood, anxiety, and sleep.
How similar studies have performed: Small trials and pilot studies of laughter therapy, play-based interventions, and gentle yoga in pediatric oncology or pain contexts have shown modest benefits for pain and anxiety, but a home-based combined laughter-and-yoga program in this specific population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Sidon
- Hammoud Hospital University Medical Center — Sidon, Lebanon (Recruiting)
Study contacts
- Principal investigator: Bahaa W Bou Dargham, MD — Beirut Arab University and Hammoud Hospital University Medical Center
- Study coordinator: Bahaa W Bou Dargham, MD
- Email: b.dargham@bau.edu.lb
- Phone: +9613537986
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.