NCT07276893

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 30, 2025

Last Update Submit

November 30, 2025

Conditions

Keywords

pediatric nursingpreoperative carechildrenanimationcardiac diseases

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

EXPERIMENTAL

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.

Behavioral: animated film via virtual reality glasses

Control group

NO INTERVENTION

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.

Interventions

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

Animated film using virtual reality glasses group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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)

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Hatice Uzsen, Phd

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR
  • Dilek Zengin, Phd

    Ege University

    STUDY DIRECTOR

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
Model Details: This parallel-group randomized controlled experimental study was designed to determine the effect of showing an animated film using virtual reality glasses to pediatric patients undergoing cardiac catheterization and the routine procedure on surgery-related anxiety, fear, and postoperative pain. Stratified Block Randomization Method were used. 1 (Experimental Group) and 2 (Control Group): The randomizer.org website was used to create the blocks.
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

Locations