Preop Preparation Before Cardiac Catheterization

NCT ID: NCT07276893

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-09-30

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.

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.

Conditions

Cardiac Abnormalities; Preoperative Care; Children; Pediatric Nursing; Animation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

animated film via virtual reality glasses

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

animated film via virtual reality glasses

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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,

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Uzşen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Uzsen, Phd

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Dilek Zengin, Phd

Role: STUDY_DIRECTOR

Ege University

Locations

Ege University

Izmir, Aegean Sea Zone, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024/228

Identifier Type: -

Identifier Source: org_study_id