Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 3:15 PM
Study NCT ID:
NCT06772259
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2024-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effect of Two Different Interventions
Sponsor:
Sakarya University
Organization:
Study Overview
Official Title:
Comparison of the Effect of Two Different Interventions on Pain and Fear in Peripheric Intravenous Catheterization in Children: a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-12
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:
PIK
Brief Summary:
The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years.
Hypotheses:
H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.
H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.
H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.
H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.
H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.
H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.
H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.
H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.
H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.
H10: PIK application time is different in the palm stimulator group compared to the control group.
H11: PIK application time is different in the cartoon group compared to the co
Hypotheses:
H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.
H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.
H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.
H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.
H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.
H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.
H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.
H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.
H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.
H10: PIK application time is different in the palm stimulator group compared to the control group.
H11: PIK application time is different in the cartoon group compared to the co
Detailed Description:
1. To measure the pain and fear levels of children by placing a palm stimulator on their palms during PIK application
2. Measuring pain and fear levels by watching cartoons to children during PIK application
2. Measuring pain and fear levels by watching cartoons to children during PIK application
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?:
False
Is an FDA AA801 Violation?: