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

NCT07327138 | Recruiting

• 1 other identifier: IRB-Jun2025-IX
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Does adding laughter and fun yoga to usual care lower pain levels in children receiving chemotherapy?
2. 2.Does this program reduce the need for strong pain medicines, such as opioids?
3. 3.Does the program help improve mood, anxiety, and sleep during treatment?
4. 4.Be randomly assigned to either the laughter and fun yoga group or the usual care group
5. 5.Take part in the study during a 6-day period after receiving their chemotherapy treatment
6. 6.Have their pain measured once each day using a child-friendly pain scale
7. 7.Have parents answer short questions about pain medicine use, mood, anxiety, and sleep

Conditions

Acute Lymphoblastic Leukemia ALL

Keywords

Acute Lymphoblastic Leukemia; Chemotherapy; Steroids; Pediatric Oncology; Pain Management; Cancer-related Pain; Laughter Therapy; Yoga Therapy; Non-pharmacological Intervention; Home-based Intervention; Supportive Cancer Care

Outcome Measures

Primary Outcomes (1)

• Mean Pain Intensity on Days 5 and 6

  Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale (FPS-R), a validated, child-friendly self-report tool that uses facial expressions anchored to numerical values from 0 (no pain) to 10 (worst pain). Pain will be assessed once daily at a consistent time using a standardized parent-read script, and the child will select the face that best represents their pain at that moment. Scores will be recorded immediately after assessment. The primary endpoint is defined as the average pain score measured on Day 5 and Day 6 post chemotherapy and steroid administration, corresponding to the expected peak dexamethasone-related pain window. If only one of these two measurements is available, that value will be used as the primary outcome.

  Days 5 and 6 post chemotherapy and steroid administration

Secondary Outcomes (5)

• Daily pain trajectory (Wong-Baker FACES)

  From Day 0 to Day 6 post chemotherapy and steroid administration

• Analgesic use (opioids only)

  From Day 0 to Day 6 post chemotherapy and steroid administration

• Depression

  Day 0 and Day 6

• Anxiety

  Day 0 and Day 6

• Sleep Quality

  Day 0 and Day 6

Study Arms (2)

Laughter and Fun Yoga Plus Usual Care

EXPERIMENTAL

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.

Behavioral: Laughter and Fun Yoga Program

Usual Care Only

NO INTERVENTION

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.

Interventions

Laughter and Fun Yoga Program BEHAVIORAL

This intervention consists of a structured, home-based laughter and fun yoga program delivered over six consecutive days. The program combines guided video-based sessions with daily activity packages containing materials for age-appropriate playful activities. The activities include gentle fun yoga movements, breathing exercises, laughter-based exercises, guided play, and positive affirmation. Parents or caregivers supervise and actively participate with the child throughout the program. The intervention is designed to be non-invasive, low intensity, and safe for children receiving chemotherapy, and it is provided in addition to standard medical and supportive care.

Laughter and Fun Yoga Plus Usual Care

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahaa Bou Dargham: lead
• Beirut Arab University: collaborator
• Hammoud Hospital University Medical Center: collaborator

Study Sites (1)

Hammoud Hospital University Medical Center

Sidon, Lebanon

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Agnosia; Cancer Pain

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Bahaa W Bou Dargham, MD

  Beirut Arab University and Hammoud Hospital University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahaa W Bou Dargham, MD

CONTACT

+9613537986; b.dargham@bau.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)