Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-28 @ 3:51 PM
Study NCT ID:
NCT05818761
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2023-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Sponsor:
Dokuz Eylul University
Organization:
Study Overview
Official Title:
The Effects of Virtual Reality and Stress Ball Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Status:
COMPLETED
Status Verified Date:
2023-05
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:
VR-DEU22
Brief Summary:
This randomized controlled study was planned to evaluate the effects of distraction methods, using virtual reality or a stress ball, on the emotional appearance, pain, fear, and anxiety associated with the procedure, during the phlebotomy in children aged 6-12 in a private blood collection unit.
Detailed Description:
H1: There is a difference between the groups in terms of pain, fear, anxiety and emotional appearance scores related to the intervention during the blood draw attempt.
A standard approach will be applied to all children. Standard approach; giving information about the procedure, the nurse introducing herself, choosing the area together, being with the parent and talking to the child during the procedure, "I'm starting now, I'm cleaning the area, take a deep breath, I'm applying it now, it may hurt a little, you shouldn't move, it will take a very short time, I will cover it with tape " contains.
In the virtual reality glasses group, a tourniquet will be attached to the extremity where the intervention will be performed. By wearing virtual glasses, the video will be started.
In the stress ball group, before the intervention is applied, the other hand will be given a stress ball and asked to squeeze it.
In the control group, communication with the child will continue during the intervention with the questions mentioned above.
When the nurse decides on the area where the PICT will be performed (the minute will be recorded), she will use the words "I am cleaning the area, take a deep breath, now I am applying the injection, it may hurt a little, you should not move, it will be very short".
The intervention will be stopped when the blood draw attempt fails in all groups.
5 minutes after the blood draw attempt, the child will be asked to rate the most painful moment felt during the procedure using the Facial Expressions Rating Scale. The Child Fear Scale (CDS) and Child Anxiety Scale-State (CAS-D) will be given to the child to assess how anxious and frightened he is during the procedure. The child will be asked to mark with a pencil. The Emotional Appearance Scale for Children will be evaluated by the nurse after the procedure.
A standard approach will be applied to all children. Standard approach; giving information about the procedure, the nurse introducing herself, choosing the area together, being with the parent and talking to the child during the procedure, "I'm starting now, I'm cleaning the area, take a deep breath, I'm applying it now, it may hurt a little, you shouldn't move, it will take a very short time, I will cover it with tape " contains.
In the virtual reality glasses group, a tourniquet will be attached to the extremity where the intervention will be performed. By wearing virtual glasses, the video will be started.
In the stress ball group, before the intervention is applied, the other hand will be given a stress ball and asked to squeeze it.
In the control group, communication with the child will continue during the intervention with the questions mentioned above.
When the nurse decides on the area where the PICT will be performed (the minute will be recorded), she will use the words "I am cleaning the area, take a deep breath, now I am applying the injection, it may hurt a little, you should not move, it will be very short".
The intervention will be stopped when the blood draw attempt fails in all groups.
5 minutes after the blood draw attempt, the child will be asked to rate the most painful moment felt during the procedure using the Facial Expressions Rating Scale. The Child Fear Scale (CDS) and Child Anxiety Scale-State (CAS-D) will be given to the child to assess how anxious and frightened he is during the procedure. The child will be asked to mark with a pencil. The Emotional Appearance Scale for Children will be evaluated by the nurse after the procedure.
Study Oversight
Has Oversight DMC:
False
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?: