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Recruiting Phase 3

Artistic and Movement Activities to Reduce Anxiety in Children With Acute Lymphoblastic Leukemia.

NCT07878065 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2026-01-21
Last updated
2026-10-16

Condition(s) studied

AnxietyAcute Leukemia

Investigational drug(s) / intervention(s)

Art and physical activity program.

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.

Study 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

Sex
ALL
Min age
8 Years
Max age
13 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Spence Children's Anxiety Scale, Arabic translation by Dr. Abdel Aziz Mousa — 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

Trial sites (1)

FacilityCityRegionStatus
Children's cancer hospital 57357 Cairo Cairo Governorate Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07878065 on ClinicalTrials.gov ↗ ← All trials in Egypt