The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision

The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision: A Randomized Controlled Study

The aim of this study is to investigate the effect of virtual reality and cartoons and games on the anxiety, fear and post-procedural pain levels of children aged 7-12 years who will undergo circumcision. The population of the study will consist of children aged 7-12 years who are planned to undergo circumcision in the pediatric urology clinic of İzmir Bakırçay University Çiğli and Training and Research Hospital between September 2024 and September 2025. The sample of the study will consist of children who meet the inclusion criteria on the specified dates and whose parents/legal guardians and themselves agree to participate in the study. Descriptive Characteristics Form, Vital Symptom Form, Child Fear Scale, Child Anxiety Scale-Disposition (CAS-D) and Child Fear Scale will be used to collect the data.

Study Overview

• Status: Recruiting
• Conditions: Virtual Reality
• Intervention / Treatment: Other: Virtual Reality-Game group; Other: Virtual Reality-Cartoon-video group

Detailed Description

Virtual Reality-Game group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the game group will be allowed to choose a game compatible with virtual reality. Children in this group will be allowed to play the game of their choice for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.

Virtual Reality-Cartoons-Video group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the cartoon-video group will be allowed to choose a cartoon of their choice compatible with virtual reality. Children in this group will be allowed to watch the cartoon of their choice for 10-15 minutes before the procedure. In terms of infection risk, VR will be disinfected before and after each use.

Control group Children in the control group will not be subjected to any distraction method. The routine procedure of the clinic will be applied.

Data Collection Phase 1: The study will start after ethics committee and institutional permissions are obtained. The researcher will inform the children and their parents about the study and the verbal and written consent of the participants will be obtained. Children who will undergo circumcision will be randomly assigned to the VR groups or the control group.

Phase 2: "Descriptive Characteristics Form", 'Child Fear Scale', 'Child Anxiety Scale-Conditionality (CAS-D)' will be completed for children in all groups before the circumcision procedure.

Phase 3: Children in the VR-game group will be asked to play a game of their choice for 10-15 minutes before the procedure. Children in the VR-cartoon-video group will be asked to watch a cartoon of their choice for 10-15 minutes.

Stage 4: Before the procedure, the physiologic parameters of the children in all groups will be recorded on the "Vital Signs Record Form".

5. After the procedure, "Child Fear Scale", "Child Anxiety Scale-Conditioning (CAS-D)" and "Visual Analog Scale" and "Life Findings Record Form" will be filled out for the children in all groups.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eliz Geçtan; Phone Number: 05451342435; Email: elizgectan09@gmail.com

Study Locations

• Turkey
  • Izmir, Turkey
    • Recruiting
    • Izmir Bakircay University Cigli Training and Research Hospital
    • Contact: Eliz Geçtan; Phone Number: 05451342435; Email: elizgectan09@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children between the ages of 7 and 12,
• The parent/legal guardian or the child himself/herself agrees to participate in the study
• Has not undergone any surgical operation before
• He was hospitalized for a circumcision
• No communication problems (visual, hearing, mental)

Exclusion Criteria:

• Chronic pain
• Eyeglass wear

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental;:Virtual Reality-Game group; Virtual Reality-Game group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the game group will be allowed to choose a game of their choice compatible with virtual reality. Children in this group will be allowed to play the game of their choice for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.	Other: Virtual Reality-Game group; Children in the play group will be allowed to choose a game that is compatible with virtual reality. Children in this group will be allowed to play the game they want for 10-15 minutes before the procedure. VR will be disinfected before and after each use
Experimental: Experimental: Virtual Reality-Cartoon group; Virtual Reality-Cartoon group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the cartoon-video group will be allowed to choose a cartoon of their choice compatible with virtual reality. Children in this group will be allowed to watch the cartoon of their choice for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.	Other: Virtual Reality-Cartoon-video group; Children in the cartoon-video group will be allowed to choose a cartoon they want compatible with virtual reality. Children in this group will be allowed to watch the cartoon they want for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.
No Intervention: No Intervention; Children in the control group will not be subjected to any distraction method. The routine procedure of the clinic will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear assesed by Child Fear Scale	The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.	Procedure -Before the circumcision
Fear assesed by Child Fear Scale	The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.	Procedure -After the circumcision
Anxiety assesed by Children Anxiety Meter-State	The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10).	Procedure -Before the circumcision
Anxiety assesed by Children Anxiety Meter-State	The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10).	Procedure -After the circumcision
Visual Analog Scale	The extremes of the line are 0 (no pain at all) and 10 (unbearable pain). In pain assessment with this scale, the child is asked to place a mark on a point between 0 and 10 to indicate the level of pain or to express it verbally	Procedure -After the circumcision

Secondary Outcome Measures

Outcome Measure	Time Frame
Children's heart rate	Procedure -Before the circumcision
Children's heart rate	Procedure -After the circumcision
Children's respiratory rate	Procedure -Before the circumcision
Children's respiratory rate	Procedure -After the circumcision
Children's oxygen saturation	Procedure -Before the circumcision
Children's oxygen saturation	Procedure -After the circumcision

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): September 19, 2025
• Study Completion (Estimated): September 19, 2025

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: pain; anxiety; virtual reality; fear
• Other Study ID Numbers: 1734

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No