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

NCT07327138 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Acute Lymphoblastic Leukemia ALL

Interventions

BEHAVIORAL

Laughter and Fun Yoga Program

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.

Sponsors & Collaborators

  • Beirut Arab University

    collaborator OTHER

  • Hammoud Hospital University Medical Center

    collaborator OTHER_GOV

  • Bahaa Bou Dargham

    lead OTHER

Principal Investigators

  • Bahaa W Bou Dargham, MD · Beirut Arab University and Hammoud Hospital University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07327138 on ClinicalTrials.gov