Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483087
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-03-21
Brief Title:
Effect of Animated Education on Anxiety and Vascular Complications
Sponsor:
University of Jordan
Organization:
University of Jordan
Study Overview
Official Title:
The Effect of Animated Education Program on Anxiety Vascular Complications And Flat Time Among Children Undergoing Cardiac Catheterization
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAEdA
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
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 childrens medical records and contact their cardiologists The researcher will introduce herself to the study participants a simple explanation of the studys 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 childrens 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 childrens 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 childrens 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 Childrens 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 researchers assistance data collector to read the tool for them if they find difficulties in reading Childrens 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
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 childrens 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 childrens 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 childrens 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 Childrens 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 researchers assistance data collector to read the tool for them if they find difficulties in reading Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None