- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07276893
Preop Preparation Before Cardiac Catheterization (Preparation)
Preparation of the Pediatric Patient Before Cardiac Catheterization: A Randomized Controlled Trial
This study aimed to determine the effect of an animated film shown through virtual reality (VR) glasses before cardiac catheterization on children's pre-procedure anxiety and fear levels and post-procedure pain. H1: Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.
H2: Animated films viewed through virtual reality glasses reduce procedure-related fear in children.
H3: Animated films viewed through virtual reality glasses reduce procedure-related pain in children.
Prior to the cardiac catheterization procedure, the researcher administered the Individual Assessment Form and the Children's Fear Scale to the children and had them complete the Children's Anxiety Scale-State Scale. One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses. After the animated film was shown to the child, the Child Anxiety Scale-State (CAS-D) was administered, and the Child Fear Scale was assessed by the researcher. Thirty minutes after the cardiac catheterization procedure was completed and the child returned to the children's ward, the researcher evaluated the Child Fear Scale and Wong Baker Facial Pain Scale and had the child complete the Child Anxiety Scale-State (CAS-D). Additionally, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.
Study Overview
Status
Intervention / Treatment
Detailed Description
Healthcare professionals have developed preoperative preparation programs that include methods such as short films, videos, picture books, play activities, and surgical room tours to help children cope with surgical procedures and reduce negative reactions. These methods are low-cost, minimally invasive, have a minimal risk of adverse effects, and are continuously and widely applicable to various diseases. Studies indicate that animated videos used to distract children's attention before surgery reduce preoperative anxiety (Özyılmaz et al., 2024; Yang et al., 2022) and increase compliance during surgery (Yang et al., 2022).
This study aimed to determine the effect of an animated film shown through virtual reality (VR) glasses before cardiac catheterization on children's pre-procedure anxiety and fear levels and post-procedure pain. H1: Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.
H2: Animated films viewed through virtual reality glasses reduce procedure-related fear in children.
H3: Animated films viewed through virtual reality glasses reduce procedure-related pain in children.
Prior to the cardiac catheterization procedure, the researcher administered the Individual Assessment Form and the Children's Fear Scale to the children and had them complete the Children's Anxiety Scale-State Scale. One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses. After the animated film was shown to the child, the Child Anxiety Scale-State (CAS-D) was administered, and the Child Fear Scale was assessed by the researcher. Thirty minutes after the cardiac catheterization procedure was completed and the child returned to the children's ward, the researcher evaluated the Child Fear Scale and Wong Baker Facial Pain Scale and had the child complete the Child Anxiety Scale-State.
Control GRoup Prior to cardiac catheterization, the researcher administered the Individual Assessment Form and the Children's Fear Scale to the children and had them complete the Children's Anxiety Scale-State Scale. Children in this group continued to undergo routine procedures at the clinic. Half an hour after the cardiac catheterization procedure was completed and the child returned to the children's ward, the researcher administered the Children's Fear Scale and the Wong Baker Facial Pain Scale and ensured that the child completed the Children's Anxiety Scale, State (CAS-D) Scale. In addition, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.(CAS-D). Additionally, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aegean Sea Zone
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Izmir, Aegean Sea Zone, Turkey (Türkiye), 35100
- Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Being a child patient aged 5-10 years old hospitalized in the Cardiology Clinic of Ege University Hospital (Health Application and Research Center) Children's
- Hospital and scheduled for cardiac catheterization,
- The child being able to read and write,
- Having developed language skills/no communication problems,
- The family agreed to participate in the study,
- The child volunteered to participate in the study, Exclusion Criteria
- Having vision problems or wearing glasses,
- Having a psychological diagnosis,
- Not being able to understand or speak Turkish,
- The child did not want to complete the scales after the procedure,
- The child or parent wanting to withdraw from the study,
- Not agreeing to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animated film using virtual reality glasses group
Prior to the cardiac catheterization procedure, the researcher administered the Individual Assessment Form and the Children's Fear Scale to the children and had them complete the Children's Anxiety Scale-State Scale.
One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses.
After the animated film was shown to the child, the Child Anxiety Scale-State (CAS-D) was administered, and the Child Fear Scale was assessed by the researcher.
Thirty minutes after the cardiac catheterization procedure was completed and the child returned to the children's ward, the researcher evaluated the Child Fear Scale and Wong Baker Facial Pain Scale and had the child complete the Child Anxiety Scale-State (CAS-D).
Additionally, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.
|
One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses.
|
|
No Intervention: Control group
Prior to cardiac catheterization, the researcher administered the Individual Assessment Form and the Children's Fear Scale to the children and had them complete the Children's Anxiety Scale-State Scale.
Children in this group continued to undergo routine procedures at the clinic.
Half an hour after the cardiac catheterization procedure was completed and the child returned to the children's ward, the researcher administered the Children's Fear Scale and the Wong Baker Facial Pain Scale and ensured that the child completed the Children's Anxiety Scale, State (CAS-D) Scale.
In addition, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Anxiety Scale
Time Frame: One hour before the procedure, 30 minutes after the procedure
|
Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.
|
One hour before the procedure, 30 minutes after the procedure
|
|
Child Fear Scale
Time Frame: one hour before the procedure, 30 minutes after the procedure
|
Animated films viewed through virtual reality glasses reduce procedure-related fear in children.
|
one hour before the procedure, 30 minutes after the procedure
|
|
Wong Baker Facial Pain Scale
Time Frame: Thirty minutes after the procedure
|
Animated films viewed through virtual reality glasses reduce procedure-related pain in children.
|
Thirty minutes after the procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hatice Uzsen, Phd, Ondokuz Mayıs University
- Study Director: Dilek Zengin, Phd, Ege University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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