Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy. (NCT07327138) | Clinical Trial Compass
RecruitingNot Applicable
Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy.
Lebanon60 participantsStarted 2025-10-15
Plain-language 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.
Who can participate
Age range
2 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Pain Intensity on Days 5 and 6
Timeframe: Days 5 and 6 post chemotherapy and steroid administration