Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-29 @ 11:38 AM
Study NCT ID:
NCT05012904
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2021-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer
Sponsor:
Mehmet Akif Ersoy University
Organization:
Study Overview
Official Title:
Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer: A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-01
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:
This study aims to determine whether parental involvement during venipuncture reduces venipuncture pain and anxiety in children with cancer.
Detailed Description:
This was a randomized controlled trial with parallel groups in which 60 children with cancer aged 6-12 were randomly allocated to a control group (n = 30) and a parent involvement group (n = 30). Each child's anxiety was evaluated by the child using the Children's Fear Scale before, during venipuncture, and each child's pain during the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during the procedure.
Control group (n = 30): Routine venipuncture procedure was applied to the control group. The parent was present in the child's room but did not participate in the procedure.
Parent involvement group (n = 30): A parent was involved in the procedure. The parent held the children in their arms and holding the extremity from which the blood was drawn, holding the hands of children and communicating with their children in the child's room, and in this way the parent was involved in the procedure.
Control group (n = 30): Routine venipuncture procedure was applied to the control group. The parent was present in the child's room but did not participate in the procedure.
Parent involvement group (n = 30): A parent was involved in the procedure. The parent held the children in their arms and holding the extremity from which the blood was drawn, holding the hands of children and communicating with their children in the child's room, and in this way the parent was involved in 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?: