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NCT07878065
Artistic and Movement Activities to Reduce Anxiety in Children With Acute Lymphoblastic Leukemia.
Conditions: Anxiety, Acute Leukemia
Sex: All
Ages: 8 Years – 13 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 76
Sponsor: Children's Cancer Hospital Egypt 57357
Location: Children's cancer hospital 57357 Cairo Cairo Governorate
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07878065). StuddyBuddy aggregates publicly available trial information.