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.
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 10
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Lebanon
Hammoud Hospital University Medical Center
RECRUITING
Sidon
Contact Information
Primary
Bahaa W Bou Dargham, MD
b.dargham@bau.edu.lb
+9613537986
Time Frame
Start Date:2025-10-15
Estimated Completion Date:2026-12
Participants
Target number of participants:60
Treatments
Experimental: Laughter and Fun Yoga Plus Usual Care
Participants randomized to this arm will receive the Magic Box Laughter and Fun Yoga Program in addition to usual care. The intervention is a structured, home-based program delivered over six consecutive days and supported by guided videos and daily activity packages. On the hospital visit day, parents receive an introduction video, the Magic Box, and six numbered packages, along with instructions and daily follow-up arrangements. Each day, parents receive a short video guiding age-appropriate activities that combine gentle fun yoga, breathing exercises, laughter-based exercises, and playful activities using materials provided in the daily packages. Parents actively supervise and participate with the child throughout the program. The intervention concludes with a celebratory session focused on positive affirmation and engagement. All participants continue to receive standard medical and supportive pain management according to institutional protocols.
No_intervention: Usual Care Only
Participants randomized to this arm will receive usual care only, consisting of routine pharmacological and supportive pain management according to each participating center's pediatric oncology protocols. This may include analgesic medications, such as opioids if clinically indicated, as well as general supportive measures including rest, hydration, and comfort care. No structured laughter therapy, yoga activities, or other psychosocial interventions will be provided as part of the study. All participants in this arm will continue to receive standard medical care throughout the study period.