Health TrialsbyHealthPanel

Effect of Animated Education on Anxiety and Vascular Complications

ConditionCardiac Catheterization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Jordan

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged between 6-12 years

admitted for their first scheduled cardiac catheterization non-emergency CC procedure.

Disqualifiers

children with developmental delay

emergency CC because

having major hearing or visual difficulties

children have deteriorated health conditions before CC and need to be admitted for intensive care before undergoing CC

Trial design

Design model

Parallel

Treatments tested in this trial

  • Animated Education Program

    Behavioral

    Eight minutes animated vedio; presented individually to children in their rooms. The vedio explains specific aspectsof the cardiac cathetrization procedure.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: the intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Day 1

Secondary outcomes

1

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).

Time frame
Day 1, Day 2, Day 3
2

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).

Time frame
Day1
3

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

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Jordan

Lead sponsor

Jordanian Royal Medical Services

Collaborator

Source ClinicalTrials.gov
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