Actively Recruiting
Home-based Laughter and Fun Yoga Program to Reduce Pain in Children with Acute Lymphoblastic Leukemia Receiving Chemotherapy
Led by Bahaa Bou Dargham · Updated on 2026-01-08
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Bahaa Bou Dargham
Lead Sponsor
B
Beirut Arab University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate if a home-based program combining laughter and fun yoga can reduce pain in children aged 2 to 10 years with acute lymphoblastic leukemia who are receiving chemotherapy and steroids. The study examines whether adding these activities to usual care lowers pain levels, reduces the need for strong pain medicines like opioids, and improves mood, anxiety, and sleep during treatment. Participants are randomly assigned to one of two groups: one group receives the Magic Box Laughter and Fun Yoga Program alongside usual care, while the other group receives usual care alone. The intervention is delivered over six consecutive days at home, involving gentle yoga movements, breathing exercises, laughter activities, and guided play through daily videos and activity packages. Parents supervise and participate to ensure safety and engagement. All children continue their regular medical care throughout the study. During the six-day study period following chemotherapy, pain is measured daily using a child-friendly scale, and parents provide information about pain medication use, mood, anxiety, and sleep through short questionnaires. The main outcome focuses on mean pain intensity on days five and six after chemotherapy. Researchers also monitor daily pain trends, opioid use, and psychological well-being. This approach aims to support children’s comfort and overall experience during cancer treatment.
CONDITIONS
Brief Title
Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 10 years
- Diagnosed with acute lymphoblastic leukemia (ALL) and currently receiving chemotherapy including dexamethasone pulses during maintenance
- 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 home-based intervention sessions
- Written informed consent from parent/legal guardian, with age-appropriate assent from the child
You will not qualify if you...
- Recent major surgery within the past 2 weeks that may limit safe participation in gentle activity
- Severe uncontrolled medical conditions such as unstable vital signs, decompensated cardiac or respiratory disease, or uncontrolled epilepsy
- Severe visual, hearing, or cognitive impairment that prevents engagement with video-based instructions and exercises
- Physical limitations or musculoskeletal injuries preventing participation in the intervention
- Any other condition judged by the treating physician to interfere with safe participation or adherence
- Currently enrolled in another interventional clinical trial for pain management
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during routine chemotherapy
Duration - 1 day
Participants undergo baseline assessment prior to randomization during routine chemotherapy visits.
1 visit (in-person)
Duration - 6 days
Participants randomized to the intervention group follow a structured, home-based laughter and fun yoga program delivered over six consecutive days. Parents or caregivers supervise and actively participate with the child throughout the intervention. This is in addition to standard medical and supportive care.
Daily home sessions guided by videos and activity packages
Duration - 6 days
Participants randomized to the control group receive routine pharmacological and supportive pain management according to institutional protocols during the study period.
Standard care during routine visits
Duration - 7 days (Day 0 to Day 6 post chemotherapy)
Pain intensity and psychosocial outcomes are assessed daily during the intervention period through brief parent-reported and child-friendly measures to monitor pain trajectory and other well-being outcomes.
Daily brief assessments (remote or in-person depending on routine care)
Trial Site Locations
Total: 1 location
1
Hammoud Hospital University Medical Center
Sidon, Lebanon
Actively Recruiting
Research Team
B
Bahaa W Bou Dargham, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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