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Cardiac CatheterizationVAEdANCT06483087

Effect of Animated Education on Anxiety and Vascular Complications

A study testing Animated Education Program in people with Cardiac Catheterization, run by University of Jordan at 1 site in Jordan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Cardiac Catheterization
What is being tested?
Animated Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteJordan
Study dates
1 Mar 2024to 1 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Nibras Haddad, PhD contact

NBR9210034@ju.edu.jo

Jordan1 site, 1 recruiting
  • Jorrdania royalmedical services

    Amman, 11111

    Jafar Alshraideh, +96265355000 ext. 23129, jalasad@ju.edu.jo

    jalasad@ju.edu.jo

    Recruiting

Other trials in Jordan

About this study

Official title: The Effect of Animated Education Program on Anxiety, Vascular Complications, And Flat Time Among Children Undergoing Cardiac Catheterization

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).

Read the detailed description

After ethical approvals are obtained, to facilitate the process of data collection, the researcher will contact the director of nursing and the head nurse of the pediatric cardiac clinic to inform them about the purpose, protocol, and duration of data collection. All days of the week, excluding holidays and weekends, between the hours of seven AM and four PM, recruitment, intervention, and data collecting will take place. To identify the clinical data regarding the health status of the children who will participate, the researcher will review children's medical records and contact their cardiologists. The researcher will introduce herself to the study participants, a simple explanation of the study's aims without mentioning anxiety level specifically, and the method of data collection will be clarified to gain their approval to participate in the study. Data collection for this study will be carried out for three months. Every child with parents will be interviewed individually by the researcher to collect the necessary data, and the interview will be conducted within 20 minutes. The interview will be classified into four phases (assessment phase, planning phase, implementation phase, and evaluation phase).

Assessment phase In QACHD, the schedule for the CC procedure is informed at 2 pm on the day before CC, when it is confirmed, which children will undergo CC the next day, the following steps will be followed; The researcher will approach the children and parents in the children's rooms and provide them with a description of the study phases. Children who expressed interest in participating in the study and are eligible to participate, researchers will ask their parents to sign the consent form, and the children's assent will also be obtained. The researcher will collect the baseline sociodemographic questionnaire from both study groups (Tool 1). Then randomize study groups for control and intervention as mentioned before.

Implementation phase Usual care will be presented to both study groups by the health team members in the pediatric unit. The researcher will present an animated education program individually to the children in the intervention group 24 hours before undergoing CC. To reduce interruptions during a teaching session and data collecting, a sign stating "Study in progress please do not disrupt" will be posted on the front door of the children's room. The AEP will be loaded on a laptop. The program will be presented in 12 minutes. The animated education program will familiarize children and their parents with the events occurring before, during, and after the post-CC procedure. Children's acquisition of the knowledge and skills taught in the AEP will be evaluated by using the ten-minute discussion that will be offered after they receive intervention from the researcher. Children in the intervention group will be encouraged to ask questions related to the material presented in the AEP. All answers to participants' questions will be provided based on the material available in the literature so that the same questions will be answered in the same way.

Evaluation phase:

After giving standardized instructions to respond to the SASC presented to children, children will be asked to read and answer the Arabic version of the SASC. Children will be informed to ask the researcher's assistance (data collector) to read the tool for them if they find difficulties in reading. Children's anxiety level will be assessed 2 hours before undergoing CC; based on previous literature findings CC-related anxiety is highest on the day of the procedure just before the CC procedure. Vascular complications will be assessed 2 hours post sheath removal by trained staff nurses in the pediatric ward; if vascular complications are present will be confirmed by an expert nurse who works in the CC lab. Flat time will be assessed and will be recorded after admission to the recovery area until physician discharge orders are obtained.

Being tested
Animated Education Program
Keywords
Cardiac catheterization, Anxiety, bleeding, flat time
Medical subject headings
Anxiety Disorders, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Animated Education ProgramBehavioural

    Also called AEP

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

Study groups in NCT06483087
Study groupRoleWhat they receive
the intervention groupExperimental[*]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.
Receives: Behavioral: Animated Education Program
Control groupNo interventionProvide 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Day 1

Secondary outcomes (3)
  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).

    Measured: 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).

    Measured: 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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06483087
Sponsor's protocol ID
101271-6
Acronym
VAEdA
Status last verified
Jun 2024
First submitted
21 Mar 2024
Last updated
1 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be uploaded to selected Repository

Questions about this trial

What is this clinical trial studying?

A study testing Animated Education Program in people with Cardiac Catheterization, run by University of Jordan at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jafar Alshraideh, PhD (+96277748455665355000 ext. 23129, jalasad@ju.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: Baseline, Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.

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