NCT07327138 Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy.
| 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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-10-15 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Bahaa W Bou Dargham, MD
PRINCIPAL INVESTIGATOR
Beirut Arab University and Hammoud Hospital University Medical Center
Frequently Asked Questions
Who can join the NCT07327138 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 10 Years, studying Acute Lymphoblastic Leukemia ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07327138 currently recruiting?
Yes, NCT07327138 is actively recruiting participants. Contact the research team at b.dargham@bau.edu.lb for enrollment information.
Where is the NCT07327138 trial being conducted?
This trial is being conducted at Sidon, Lebanon.
Who is sponsoring the NCT07327138 clinical trial?
NCT07327138 is sponsored by Bahaa Bou Dargham. The principal investigator is Bahaa W Bou Dargham, MD at Beirut Arab University and Hammoud Hospital University Medical Center. The trial plans to enroll 60 participants.
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