Preop Preparation Before Cardiac Catheterization
Preparation
Preparation of the Pediatric Patient Before Cardiac Catheterization: A Randomized Controlled Trial
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedFirst Submitted
Initial submission to the registry
November 30, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedDecember 11, 2025
November 1, 2025
7 months
November 30, 2025
November 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Child Anxiety Scale
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
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
Animated films viewed through virtual reality glasses reduce procedure-related pain in children.
Thirty minutes after the procedure
Study Arms (2)
Animated film using virtual reality glasses group
EXPERIMENTALPrior 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.
Control group
NO INTERVENTIONPrior 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.
Interventions
One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses.
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ege University
Izmir, Aegean Sea Zone, 35100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hatice Uzsen, Phd
Ondokuz Mayıs University
- STUDY DIRECTOR
Dilek Zengin, Phd
Ege University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Only participants were masked
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 30, 2025
First Posted
December 11, 2025
Study Start
February 1, 2025
Primary Completion
September 1, 2025
Study Completion
September 30, 2025
Last Updated
December 11, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share