Effect of Animated Education on Anxiety and Vascular Complications

NCT06483087 | Recruiting DMC

• 1 other identifier: 101271-6
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cardiac Catheterization

Keywords

Cardiac catheterization; Anxiety; bleeding; flat time

Outcome Measures

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.

  Baseline, Day 1

Secondary Outcomes (3)

• Bleeding at the cardiac catheterization site

  Day 1, Day 2, Day 3

• Hematoma at the cardiac catheterization site

  Day1

• Flat time

  Day 1

Study Arms (2)

the intervention group

EXPERIMENTAL

\[\*\]Arm Description: The Animated Education Program (AEP) and usual care interventions provided for children randomly assigned to the experimental group during the day before receiving a CC procedure. The Animated Education Program (AEP) was developed to prepare children for cardiac catheterization (CC) by improving their knowledge of CC procedures and helping them become familiar with such procedures in all phases. It will be presented as an AEP for eight minutes; it was uploaded on the researcher's laptop and was presented individually to children in their rooms.

Behavioral: Animated Education Program

Control group

NO INTERVENTION

Provide brief procedural instructions, such as time for fasting, and the need to increase the fluid intake post cardiac catheterization. However, no written or animated materials are used to provide health education for children before undergoing the CC procedure.

Interventions

Animated Education Program BEHAVIORAL

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

Also known as: AEP

the intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged between 6-12 years
• admitted for their first scheduled cardiac catheterization non-emergency CC procedure.

You may not qualify if:

• 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
• children who have bleeding disorders

Sponsors & Collaborators

• University of Jordan: lead
• Jordanian Royal Medical Services: collaborator

Study Sites (1)

Jorrdania royalmedical services

Amman, 11111, Jordan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jafar Alshraideh, PhD

CONTACT

+96277748455665355000; jalasad@ju.edu.jo

Nibras Haddad, PhD

CONTACT

NBR9210034@ju.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Parallel Randomized Control Trial (RCT) design will be utilized to test the study hypotheses. It is an experimental design where participants are assigned randomly to either receive the intervention or not, and the outcome of interest is then evaluated after the intervention.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: July 1, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 3 months after completion
• Access Criteria: on request

Locations

JO (1)