Acute Lymphoblastic Leukemia ALLCLAPNCT07327138
Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy.
A study testing Laughter and Fun Yoga Program in people with Acute Lymphoblastic Leukemia ALL, run by Bahaa Bou Dargham at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia ALL
- What is being tested?
- Laughter and Fun Yoga Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
Hammoud Hospital University Medical Center
Sidon
Fatimah Abed, +96171051404, sc.cru@hhumc.org.lb
Ghada Aoun, +9617723111 ext. 1956, medical@hhumc.org.lb
About this study
Official title: 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.
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:
Read more
- Does adding laughter and fun yoga to usual care lower pain levels in children receiving chemotherapy?
- Does this program reduce the need for strong pain medicines, such as opioids?
- 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:
- Be randomly assigned to either the laughter and fun yoga group or the usual care group
- Take part in the study during a 6-day period after receiving their chemotherapy treatment
- Have their pain measured once each day using a child-friendly pain scale
- 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.
Read the detailed 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.
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Being tested
- Laughter and Fun Yoga Program
- 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
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Agnosia, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter and Fun Yoga ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 5 and 6 post chemotherapy and steroid administration
Secondary outcomes (5)
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).
Measured: From Day 0 to Day 6 post chemotherapy and steroid administration
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.
Measured: From Day 0 to Day 6 post chemotherapy and steroid administration
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.
Measured: Day 0 and Day 6
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.
Measured: Day 0 and Day 6
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.
Measured: Day 0 and Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start15 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahaa Bou Dargham
- Sponsor type
- University, hospital or other
- Collaborators
- Beirut Arab University, Hammoud Hospital University Medical Center
- Responsible party
- Sponsor-investigator, Bahaa Bou Dargham, Beirut Arab University
- Investigators
- Bahaa W Bou Dargham, MD, Principal investigator, Beirut Arab University and Hammoud Hospital University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327138
- Sponsor's protocol ID
- IRB-Jun2025-IX
- Acronym
- CLAP
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07327138
- Acronym / sponsor ID
- CLAP / IRB-Jun2025-IX
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Keywords
- Acute Lymphoblastic Leukemia, Chemotherapy, Steroids, Pediatric Oncology, Pain Management, Cancer-related Pain, Laughter Therapy, Yoga Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bahaa Bou DarghamUniversity, hospital or other
- Collaborators
- Beirut Arab University, Hammoud Hospital University Medical Center
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does adding laughter and fun yoga to usual care lower pain levels in children receiving chemotherapy?
- Does this program reduce the need for strong pain medicines, such as opioids?
- 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:
- Be randomly assigned to either the laughter and fun yoga group or the usual care group
- Take part in the study during a 6-day period after receiving their chemotherapy treatment
- Have their pain measured once each day using a child-friendly pain scale
- 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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter and Fun Yoga Plus Usual Care | Experimental | Behavioral: Laughter and Fun Yoga ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter and Fun Yoga ProgramThis 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. | Behavioural | Laughter and Fun Yoga Plus Usual Care |
Primary outcome
Mean Pain Intensity on Days 5 and 6
Time frame: Days 5 and 6 post chemotherapy and steroid administration
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.
5 secondary outcomes
Daily pain trajectory (Wong-Baker FACES)
Time frame: From Day 0 to Day 6 post chemotherapy and steroid administration
Analgesic use (opioids only)
Time frame: From Day 0 to Day 6 post chemotherapy and steroid administration
Depression
Time frame: Day 0 and Day 6
Anxiety
Time frame: Day 0 and Day 6
Sleep Quality
Time frame: Day 0 and Day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: 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.
Related trials for Acute Lymphoblastic Leukemia ALL
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahaa W Bou Dargham, MD principal investigator
Beirut Arab University and Hammoud Hospital University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter and Fun Yoga Program in people with Acute Lymphoblastic Leukemia ALL, run by Bahaa Bou Dargham at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahaa W Bou Dargham, MD (+9613537986, b.dargham@bau.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pain Intensity on Days 5 and 6 (time frame: Days 5 and 6 post chemotherapy and steroid administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.