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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
Jordan1 site, 1 recruiting
- Recruiting
Jorrdania royalmedical services
Amman, 11111
Jafar Alshraideh, +96265355000 ext. 23129, jalasad@ju.edu.jo
jalasad@ju.edu.jo
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.
- Conditions
- Cardiac Catheterization
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted1 Jul 2024
- Study start1 Mar 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Jordanian Royal Medical Services
- Responsible party
- Principal investigator, Jafar Alshraideh, University of Jordan
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animated Education Program on Anxiety, Vascular Complications, And Flat Time Among Children Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT06483087
- Acronym / sponsor ID
- VAEdA / 101271-6
- Conditions
- Cardiac Catheterization
- Keywords
- Cardiac catheterization, Anxiety, bleeding, flat time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Jordanian Royal Medical Services
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Behavioral: Animated Education Program[*]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. |
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged between 6-12 years
- admitted for their first scheduled cardiac catheterization non-emergency CC procedure.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animated Education ProgramAlso: AEPEight minutes animated vedio; presented individually to children in their rooms. The vedio explains specific aspectsof the cardiac cathetrization procedure. | Behavioural | the intervention group |
Primary outcome
Anxiety
Time frame: Baseline, Day 1
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.
3 secondary outcomes
Bleeding at the cardiac catheterization site
Time frame: Day 1, Day 2, Day 3
Hematoma at the cardiac catheterization site
Time frame: Day1
Flat time
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Yes. De-identified data will be uploaded to selected Repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nibras Haddad, PhD contact
1 site in 1 country: see every site and its status.
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.