Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401408
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
Effect of Virtual Reality Headsets on Fear Anxiety and Physiological Parameter in Skin Prick Test
Sponsor:
TC Erciyes University
Organization:
TC Erciyes University
Study Overview
Official Title:
Effect of Virtual Reality Headsets on Pain Anxiety Fear and Physiological Parameters in Children Who Had Skin Prick Test Applied
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is determine the effect of virtual reality headsets on pain anxiety fear and physiological parameters in children aged 4-7 years who undergoing skin prick test The main questions it amis to answer are
Virtual reality headsets effect on the pain that during the procedure
Virtual reality headsets effect on the anxiety that occurs during the procedure
Virtual reality headsets effect on the fear that occurs during the procedure
Virtual reality headsets effect on physiological parameters heart rate blood pressure respiratory rate during the procedure
Virtual reality headsets effect on the pain that during the procedure
Virtual reality headsets effect on the anxiety that occurs during the procedure
Virtual reality headsets effect on the fear that occurs during the procedure
Virtual reality headsets effect on physiological parameters heart rate blood pressure respiratory rate during the procedure
Detailed Description:
Before starting the skin prick test the child and hisher family who meet the inclusion criteria of the study will be informed about the use of virtual reality headsetsVRH and volunteer consent forms will be obtained Before starting the test 5 minutes before the Introductory Characteristics Form for Children and Their Families and scales so that the pain fear and anxiety scores predicted by the children before the procedure will be measured will be applied to the children and the childs physiological parameters heart rate blood pressure respiratory rate oxygen saturation value will be taken Then the children will be fitted with an VRH and watched an animated film approximately 15 minutes long determined in line with the childs age group developmental characteristics and expert opinionsAfter the child starts watching the video skin prick test procedures will be initiated and the child will be allowed to watch the video until the test ends After the test is completed 5 minutes later physiological parameters will be taken again and scales thus measuring the pain fear and anxiety scores felt by the children during the procedure will be applied
Control group application phase
No interventionapplication will be performed on the children who will be included in the control group The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group in the form of pretest-posttest Additionally physiological parameters will be taken simultaneously with the experimental group
Control group application phase
No interventionapplication will be performed on the children who will be included in the control group The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group in the form of pretest-posttest Additionally physiological parameters will be taken simultaneously with the experimental group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None