Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy. (CLAP)

Bahaa Bou Dargham

Status: Enrolling

Conditions: Acute Lymphoblastic Leukemia ALL

Treatments: Behavioral: Laughter and Fun Yoga Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07327138

IRB-Jun2025-IX

Details and patient eligibility

About

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.

Full description

This study is a multicenter, randomized, parallel-group clinical trial evaluating the effectiveness of a structured home-based laughter and fun yoga intervention as an adjunct to standard care for the management of chemotherapy-related pain in children with acute lymphoblastic leukemia.

Participants are enrolled during routine chemotherapy visits and undergo baseline assessment prior to randomization. Using a 1:1 allocation ratio, participants are assigned to either the intervention group or the control group. Randomization is performed to ensure balanced group allocation across participating study centers.

The intervention consists of a structured program delivered at home over a six-day period. It integrates gentle, age-appropriate yoga movements, breathing exercises, laughter-based activities, and guided play. The activities are designed to be non-invasive, low intensity, and safe for children undergoing chemotherapy. Parents or caregivers supervise and actively participate in the sessions to support engagement and ensure safety. The intervention is intended to complement, not replace, standard medical care.

Participants assigned to the control group receive standard care only, which includes routine pharmacological and supportive pain management according to institutional protocols at each participating center. No structured laughter or yoga activities are provided to the control group during the study period.

Outcome data are collected through brief daily assessments conducted during the intervention period. Pain is assessed daily using a validated, child-friendly pain rating scale. Additional information on pain medication use and selected psychosocial outcomes is collected through parent-reported measures. Data collection procedures are designed to minimize participant burden and integrate smoothly into routine care.

The primary objective of the study is to determine whether the addition of a structured, non-pharmacological home-based intervention can lower pain intensity during chemotherapy. Secondary objectives include evaluating the potential impact of the intervention on pain medication use and overall well-being. The findings of this study may help inform supportive care strategies for children undergoing cancer treatment.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Laughter and Fun Yoga Plus Usual Care

Experimental group

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.

Treatment:

Behavioral: Laughter and Fun Yoga Program

Usual Care Only

No Intervention group

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.