Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622369
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
The Effect of Virtual Reality on Fear Pain and Anxiety in Children Undergoing Circumcision
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Virtual Reality on Fear Pain and Anxiety in Children Undergoing Circumcision A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 parentslegal 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None