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

Browse trials for

• Precursor Cell Lymphoblastic Leukemia-Lymphoma 2,584
• Cancer Pain 310

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

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Lead sponsor

Bahaa Bou Dargham is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  Laughter and Fun Yoga Plus Usual Care

  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

• No intervention
  Usual Care Only

  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

• BehavioralLaughter 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.

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.

   Time frame: Days 5 and 6 post chemotherapy and steroid administration

Secondary outcomes

1. Daily pain trajectory (Wong-Baker FACES)

   Daily pain will be measured using the Wong-Baker FACES Pain Rating Scale (0, 2, 4, 6, 8, 10) at a fixed evening window (17:00-20:00) on Days 0-6 to characterize the day-by-day trajectory of pain during the dexamethasone period. At each assessment, a standardized script will be read by the parent under researcher guidance, and the child will select the face that best represents their pain "right now." If no clear response is given, the script may be repeated once without prompting toward any choice. Scores will be recorded immediately on the CRF with date and time. This outcome provides a daily series of FPS-R values across the 7-day observation window, enabling description of within-week pain patterns and comparison of peak timing and magnitude between groups, complementary to the primary endpoint (Day 5-6 average).

   Time frame: From Day 0 to Day 6 post chemotherapy and steroid administration

2. Analgesic use (opioids only)

   Opioid analgesic use will be assessed during the dexamethasone and chemotherapy period, as non-opioid analgesics are not routinely used during this phase. Opioid exposure will be measured by converting all administered opioid doses to oral morphine milligram equivalents (MME), including cumulative 6-day MME and weight-adjusted MME per kilogram. Additional measures include time from chemotherapy and dexamethasone administration to first rescue opioid dose, number of rescue opioid doses, and the proportion of participants requiring any opioid analgesia. Emergency department visits for pain control during the study period will also be recorded, including opioid administration and disposition when applicable.

   Time frame: From Day 0 to Day 6 post chemotherapy and steroid administration

3. Depression

   Depressive symptoms will be assessed using the Arabic Short Mood and Feelings Questionnaire - Parent version (SMFQ-P), a 13-item parent-reported questionnaire that evaluates core depressive symptoms such as sadness, loss of interest, irritability, fatigue, guilt, and low self-esteem. Each item is rated on a 3-point scale ("not true," "sometimes true," "true"), with total scores ranging from 0 to 26; higher scores indicate greater depressive symptom severity. The Arabic SMFQ-P has been validated in Lebanon and is appropriate for use in research settings. The questionnaire will be administered to parents at baseline (Day 0) and at the end of the intervention period (Day 6). For younger children, the tool will be completed as a parent-proxy measure focusing on observable mood and behavior.

   Time frame: Day 0 and Day 6

4. Anxiety

   The SCARED-5 (5-item Screen for Child Anxiety Related Emotional Disorders) is a brief parent-report screening tool used for youth anxiety. Although an Arabic validation of the short version is not yet available, the full Arabic SCARED-P (41-item parent version) has demonstrated excellent psychometric properties in Lebanon (a = 0.92, convergent validity with SDQ Emotional, discriminant validity). The SCARED-5 has undergone a recent psychometric evaluation, showing strong internal consistency, single-factor structure, good correlation with the full scale, and a suggested cutoff score of ≥ 2 for identifying anxiety. Based on this evidence, we will use the Arabic version of the items from the validated full SCARED-P, structured as the SCARED-5, and apply a clinical alert threshold of ≥ 2. In younger children (age \<6), scores will be treated as exploratory and interpreted with caution.

   Time frame: Day 0 and Day 6

5. Sleep Quality

   Sleep will be assessed using the Arabic Sleep Disturbance Scale for Children (SDSC), a 26-item parent-reported questionnaire that evaluates common pediatric sleep problems, including difficulties with sleep initiation and maintenance, breathing-related sleep disturbances, arousal disorders, excessive daytime sleepiness, and sleep-wake transition problems. Each item is rated on a 5-point scale, with higher total scores indicating greater sleep disturbance. The SDSC will be administered at baseline (Day 0) and at the end of the intervention period (Day 6). The primary sleep outcome is the change in total SDSC score from baseline to Day 6. For younger children, results will be exploratory. Participants with markedly elevated scores will be flagged and referred to the treating physician for clinical follow-up.

   Time frame: Day 0 and Day 6

Individual participant data

Plan to share: No — Individual participant data will not be shared. This study involves pediatric participants and includes sensitive clinical and psychosocial information. Data sharing is not planned due to privacy considerations and local institutional and ethical requirements.