Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560320
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Effect of Using Virtual Reality Goggles on Fear and Pain Level During Vaccination in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Using Virtual Reality Goggles on Fear and Pain Level During Vaccination in Children A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-08
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 study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses reducing fear and pain during routine vaccination in children
Detailed Description:
In the literature it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain In light of this information this study aimed to examine the effect of distraction by using Virtual Reality Glasses in reducing fear and pain during routine vaccination in children
This study is a prospective randomized and controlled trial Children aged 48 months who required routine vaccination were divided into two groups Virtual Reality Glasses and Control Data were obtained through face-to-face interviews with the children their parents and the observer before and after the procedure The childrens anxiety levels were also assessed using the Childrens Fear Scale The childrens pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES
The study population consisted of the childrens during routine vaccination in children aged 48 months Sample of the study consisted of a total of 64 children who met the sample selection criteria and were selected via randomization method
Children were randomized into two groups Virtual Reality Glasses group n 32 and Control group n 32 Data were collected using the Interview and Observation Form Childrens Fear Scale and Wong-Baker FACES Pain Rating Scale
This study is a prospective randomized and controlled trial Children aged 48 months who required routine vaccination were divided into two groups Virtual Reality Glasses and Control Data were obtained through face-to-face interviews with the children their parents and the observer before and after the procedure The childrens anxiety levels were also assessed using the Childrens Fear Scale The childrens pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES
The study population consisted of the childrens during routine vaccination in children aged 48 months Sample of the study consisted of a total of 64 children who met the sample selection criteria and were selected via randomization method
Children were randomized into two groups Virtual Reality Glasses group n 32 and Control group n 32 Data were collected using the Interview and Observation Form Childrens Fear Scale and Wong-Baker FACES Pain Rating Scale
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