The Effect of Virtual Reality Application on Anxiety and Fear Levels of Children Planned for Daily Surgery

The Effect of Vırtual Realıty Applıcatıon on the Anxıety and Fear Levels of Chıldren Who Are Planned for Daıly Surgery

Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).

Study Overview

• Status: Completed
• Conditions: Child; Anxiety; Fear
• Intervention / Treatment: Device: virtual reality glasses; Device: virtual reality goggles

Detailed Description

Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bitlis, Turkey, 13000
    • Bitlis Il Sağlık Müdürlüğü

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Not having an audiovisual disease

Exclusion Criteria:

Having an audiovisual disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Data Collection; Equal numbers (n) (40:40) were included in the intervention and control groups by block randomization. Written informed consent was obtained from the parents and verbal consent was obtained from the children. Blood pressure and heart pulse was measured with the same calibrated devices throughout the study. The first and last measurements were evaluated by the researcher. In the intervention group five experts were consulted in order to involve children in the decision-making process. Three minutes and two six-minute video options. The videos show the forest, trees, flowers and 3D animated videos with animals and instrumental music were shown. Video maximum 30 minutes after being monitored. Both intervention and control group underwent the procedures to be applied in the preoperative period. The control group was not shown a video and only ward routines were applied.	Device: virtual reality glasses; Animation video application with virtual glasses by the researcher himself was applied. The application was performed in a quiet environment in the patient's room, in a sitting area where the child was comfortable. position and wearing virtual goggles over his eyes.; Device: virtual reality goggles; vr 360 degree screen viewing
No Intervention: control group; Routine maintenance was provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child fear scale	Child Fear Scale ranges from neutral (0 points=no fear) to frightened It consists of five different statements ranging up to one hundred (4 points=severe fear). Horror score the higher the level of fear, the higher the level of fear	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale modified preoperative anxiety scale pediatric form	In the scale consisting of four parts, points are evaluated all sections are scored within each section and the highest score in its section is divided by the grade. The scores from all sections are added up, divided by 4 again, and then divided by 100. is multiplied. This calculation results in a score between 22.92-100. High score refers to high anxiety and worry.	6 months

Collaborators and Investigators

• Sponsor: Cihat Ozyılmaz

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Child; Anxiety; Fear; Distraction
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: BİTLİS-HEM-CÖ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No