AnxietyPhase 3NCT07878065
Artistic and Movement Activities to Reduce Anxiety in Children With Acute Lymphoblastic Leukemia.
A Phase 3 study testing Art and physical activity program. in people with Anxiety and Acute Leukemia, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate whether a combined artistic and motor activity program can reduce anxiety in children aged 8-13 with acute lymphoblastic leukemia (ALL) undergoing chemotherapy at Children's Cancer Hospital Egypt 57357. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Anxiety, Acute Leukemia
- What is being tested?
- Art and physical activity program.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jan 2026to 24 Nov 2026
- Phase
- Phase 3
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 8 to 13 years old as recorded in the hospital's official records.
- Children who experience feelings of anxiety.
- Medical fitness of the patient (confirmed through medical examination under the supervision of the specialist physician) before implementing the physical abilities program.
- Being in the third stage of the treatment protocol.
Who cannot join
- Cases that are already under follow-up with the psychiatric clinic.
- Cases that miss 4 sessions of the program.
- Cases that do not suffer from anxiety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Children's cancer hospital 57357
Cairo, Cairo Governorate, 11617
Dina Elgalaly, 2025351500, delgalaly@gmail.com
About this study
Official title: The Effectiveness of an Artistic and Motor Activity Program in Reducing Anxiety Levels in Children With Acute Lymphoblastic Leukemia.
The goal of this clinical trial is to evaluate whether a combined artistic and motor activity program can reduce anxiety in children aged 8-13 with acute lymphoblastic leukemia (ALL) undergoing chemotherapy at Children's Cancer Hospital Egypt 57357. The main questions it aims to answer are:
- Does participation in the program reduce anxiety compared to standard care?
- Does the program improve psychological well-being, social interaction, and coping during treatment? Researchers will compare an experimental group (receiving the artistic and motor program) with a control group (receiving standard care only) to see if the intervention lowers anxiety scores on the Spence Children's Anxiety Scale.
Read more
Participants will:
- Be randomly assigned to either the experimental or control group.
- Complete pre- and post-intervention anxiety assessments.
In the experimental group:
- Attend 16 weekly sessions over 4 months.
- Participate in art workshops (drawing, coloring, group activities).
- Engage in motor activities (warm-up, progressive exercises, relaxation, light games, treadmill/cycling up to 5 minutes).
In the control group:
Will not be exposed to the program, with anxiety measured before and after the same period.
- Conditions
- Anxiety, Acute Leukemia
- Being tested
- Art and physical activity program.
- Keywords
- pediatric anxiety, Spence Children's Anxiety Scale (SCAS)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art and physical activity program.Behavioural
Physical Activity Program: 16 sessions over 4 months, each lasting 20-30 minutes. Includes warm-up exercises, progressive muscle activities, relaxation techniques, and group games. From the second phase, children may use a treadmill or stationary bike for up to 5 minutes.
Art Program: 16 weekly sessions over 4 months. Activities include drawing, coloring, and creative workshops to help children express emotions, reduce anxiety, and improve social interaction.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will receive a structured program combining physical activity and art workshops. They will complete pre- and post-assessments. Receives: Behavioral: Art and physical activity program. |
| Control | No intervention | Participants will complete pre- and post-assessments but will not receive the art or physical activity program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spence Children's Anxiety Scale, Arabic translation by Dr. Abdel Aziz Mousa
The Spence Scale measures 6 domains (6 subscales):
- Panic and agoraphobia
- Separation anxiety (fear of being away from mother)
- Fear of physical injury
- Social phobia
- Obsessive-compulsive symptoms
- Generalized/excessive anxiety Age range: Applied to children and adolescents aged 8-15 years.
Structure:
Contains 45 items, each with 4 response options.
Response scoring:
"Never" = 0 "Sometimes" = 1 "Often" = 2 "Always" = 3
Administration:
The child either self-reports by marking the chosen option, or the examiner reads the items aloud and records the child's answers.
Scoring:
Raw scores are summed for each of the six domains according to the designated items.
Raw scores are then converted into T-scores, adjusted for age and gender.
Classification:
0-40 = Normal Above 40 = Elevated anxiety
Measured: Baseline (pre-assessment) and after 4 months (post-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start21 Jan 2026
- Primary completion24 Oct 2026 (estimated)
- Study completion24 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fawkya Khaled Abdelmoneim, Principal investigator, Children's cancer hospital 57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878065
- Sponsor's protocol ID
- N-0063-009-025
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Artistic and Motor Activity Program in Reducing Anxiety Levels in Children With Acute Lymphoblastic Leukemia.
- ClinicalTrials.gov ID
- NCT07878065
- Acronym / sponsor ID
- N-0063-009-025
- Conditions
- Anxiety, Acute Leukemia
- Keywords
- pediatric anxiety, Spence Children's Anxiety Scale (SCAS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 16 Oct 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 evaluate whether a combined artistic and motor activity program can reduce anxiety in children aged 8-13 with acute lymphoblastic leukemia (ALL) undergoing chemotherapy at Children's Cancer Hospital Egypt 57357. The main questions it aims to answer are:
- Does participation in the program reduce anxiety compared to standard care?
- Does the program improve psychological well-being, social interaction, and coping during treatment? Researchers will compare an experimental group (receiving the artistic and motor program) with a control group (receiving standard care only) to see if the intervention lowers anxiety scores on the Spence Children's Anxiety Scale.
Participants will:
- Be randomly assigned to either the experimental or control group.
- Complete pre- and post-intervention anxiety assessments.
In the experimental group:
- Attend 16 weekly sessions over 4 months.
- Participate in art workshops (drawing, coloring, group activities).
- Engage in motor activities (warm-up, progressive exercises, relaxation, light games, treadmill/cycling up to 5 minutes).
In the control group:
Will not be exposed to the program, with anxiety measured before and after the same period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Art and physical activity program.Participants will receive a structured program combining physical activity and art workshops. They will complete pre- and post-assessments. |
| Control | No intervention | –Participants will complete pre- and post-assessments but will not receive the art or physical activity program. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 8 to 13 years old as recorded in the hospital's official records.
- Children who experience feelings of anxiety.
- Medical fitness of the patient (confirmed through medical examination under the supervision of the specialist physician) before implementing the physical abilities program.
- Being in the third stage of the treatment protocol.
Key exclusion criteria (3 listed)
- Cases that are already under follow-up with the psychiatric clinic.
- Cases that miss 4 sessions of the program.
- Cases that do not suffer from anxiety.
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 |
|---|---|---|
| Art and physical activity program.Physical Activity Program: 16 sessions over 4 months, each lasting 20-30 minutes. Includes warm-up exercises, progressive muscle activities, relaxation techniques, and group games. From the second phase, children may use a treadmill or stationary bike for up to 5 minutes. Art Program: 16 weekly sessions over 4 months. Activities include drawing, coloring, and creative workshops to help children express emotions, reduce anxiety, and improve social interaction. | Behavioural | Experimental |
Primary outcome
Spence Children's Anxiety Scale, Arabic translation by Dr. Abdel Aziz Mousa
Time frame: Baseline (pre-assessment) and after 4 months (post-assessment)
The Spence Scale measures 6 domains (6 subscales): * Panic and agoraphobia * Separation anxiety (fear of being away from mother) * Fear of physical injury * Social phobia * Obsessive-compulsive symptoms * Generalized/excessive anxiety Age range: Applied to children and adolescents aged 8-15 years. Structure: Contains 45 items, each with 4 response options. Response scoring: "Never" = 0 "Sometimes" = 1 "Often" = 2 "Always" = 3 Administration: The child either self-reports by marking the chosen option, or the examiner reads the items aloud and records the child's answers. Scoring: Raw scores are summed for each of the six domains according to the designated items. Raw scores are then converted into T-scores, adjusted for age and gender. Classification: 0-40 = Normal Above 40 = Elevated anxiety
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Fawkya Khaled Abdelmoneim principal investigator
Children's cancer hospital 57357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Art and physical activity program. in people with Anxiety and Acute Leukemia, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
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 4 inclusion and 3 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 16 Oct 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nancy Ashraf Abdellatif (+201141083507, nancy.ashraf@57357.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spence Children's Anxiety Scale, Arabic translation by Dr. Abdel Aziz Mousa (time frame: Baseline (pre-assessment) and after 4 months (post-assessment)). 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 16 Oct 2026.