Clinical trial · Interventional
Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia ALL | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laughter and Fun Yoga Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laughter and Fun Yoga Plus Usual Care
- description
- 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.
- interventionNames
- Behavioral: Laughter and Fun Yoga Program
- type
- NO_INTERVENTION
- label
- Usual Care Only
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 10 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available