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

NCT ID: NCT06883929

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-04-15

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).

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).

Conditions

Child; Fear; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

virtual reality glasses

Intervention Type: 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.

virtual reality goggles

Intervention Type: DEVICE

vr 360 degree screen viewing

control group

Routine maintenance was provided

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

virtual reality goggles

vr 360 degree screen viewing

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Not having an audiovisual disease

Exclusion Criteria

Having an audiovisual disease

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

Sponsors

Cihat Ozyılmaz

OTHER

Sponsor Role: lead

Responsible Party

Cihat Ozyılmaz

Student

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bitlis Il Sağlık Müdürlüğü

Bitlis, Bitlis, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BİTLİS-HEM-CÖ-01

Identifier Type: -

Identifier Source: org_study_id