Effect of Animated Education on Anxiety and Vascular Complications
NCT Number: NCT06483087
Acronym: VAEdA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Catheterization
Interventions: BEHAVIORAL: Animated Education Program
Sponsor: University of Jordan
Collaborators: Jordanian Royal Medical Services
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-03-01
Completion Date: 2025-04-01
Locations: Jorrdania royalmedical services, Amman, 11111, Jordan

Summary:
An animated education program about cardiac catheterization will be presented 24 hours to children in the intervention group before undergoing cardiac catheterization. While children in the control group will receive routine care. Dependent variables are (Anxiety 2 hours before undergoing cardiac catheterization, hematoma and bleeding at the catheterization site 2 hours post sheath removal, flat time post cardiac catheterization).

Primary Outcome Measures: Anxiety, The children's anxiety level will be measured 2 hours before undergoing CC. Anxiety is an Emotional state consisting of tension feelings, apprehension, nervousness, and worry, with activation or arousal of the autonomic nervous system. State anxiety is a temporary emotional state reflective of one's interpretation of a particular stressful situation. The State-Trait Anxiety Inventory for Children consists of twenty statements asking children how they feel at a particular moment. A 10-item short form of the tool in 2005 that will be used to assess children's state anxiety levels. The children's anxiety level will be measured 2 hours before undergoing CC., Baseline, Day 1
Secondary Outcome Measures: Bleeding at the cardiac catheterization site, It is caused by blood leaking from damaged blood vessels from the cardiovascular system. Bleeding may occur through skin puncture at the CC site. Blood oozing through skin puncture, around the catheter insertion site after sheath removal, will be assessed 2 hours after sheath removal, (will be assessed by inspection and palpation if present or not). It will be recorded on a sheet that the researcher will develop.

Grade 0 (no bleeding) Grade I (little bleeding at the puncture site) Grade II (Severe bleeding)., Day 1, Day 2, Day 3|Hematoma at the cardiac catheterization site, Blood stasis outside of a blood vessel. It happens when blood leaks into the surrounding tissue through a broken artery, vein, or capillary wall. Blood collects under the skin around the catheter insertion site after sheath removal, (will be assessed by inspection and palpation if present or not). The swelling surrounding the puncture site is hard, palpable, and tender (Small hematoma: \< 5 cm in diameter, large hematoma: \> 5 cm in diameter)., Day1|Flat time, The amount of time that patients are required to lie flat and restrict their movements for an extended period to prevent vascular complications after cardiac catheterization. The hours that the child stays in a flat position in bed post-sheath removal will be recorded on the sheet that the researcher will develop.

Will be recorded after admission to the recovery area until physician discharge orders are obtained.

It will be measured in hours as follows:

\< 4 Hours 4 to \<6 Hours 6-8 Hours, Day 1