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Completed

NCT Number: NCT07276893

Preop Preparation Before Cardiac Catheterization

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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Aegean Sea Zone, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

animated film via virtual reality glasses

Behavioral

One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Preparation of the Pediatric Patient Before Cardiac Catheterization: A Randomized Controlled Trial

Acronym: Preparation

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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