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

NCT06883929 | Completed DMC

• 1 other identifier: BİTLİS-HEM-CÖ-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Child; Fear; Anxiety

Keywords

Child; Anxiety; Fear; Distraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Yale modified preoperative anxiety scale pediatric form

  6 months

Study Arms (2)

Data Collection

EXPERIMENTAL

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; Device: virtual reality goggles

control group

NO INTERVENTION

Routine maintenance was provided

Interventions

virtual reality glasses DEVICE

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.

Data Collection

virtual reality goggles DEVICE

vr 360 degree screen viewing

Data Collection

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Not having an audiovisual disease

You may not qualify if:

• Having an audiovisual disease

Sponsors & Collaborators

• Cihat Ozyılmaz: lead

Study Sites (1)

Bitlis Il Sağlık Müdürlüğü

Bitlis, Bitlis, 13000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: March 19, 2025
• Study Start: January 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: April 15, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)