Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-28 @ 8:20 PM
Study NCT ID:
NCT06111534
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2023-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates
Sponsor:
Istanbul Medeniyet University
Organization:
Study Overview
Official Title:
Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates: A Quasi-experimental Study
Status:
COMPLETED
Status Verified Date:
2023-10
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 investigated the effect of maternal holding-cuddling (MHC) and paternal holding-cuddling (PHC) on heel prick pain and crying duration in healthy term neonates
Detailed Description:
Newborns undergo many painful procedures. The heel prick, or heel lancing, is a painful procedure used for newborn screening tests. It is a more painful procedure than other venipuncture procedures. All pediatricians and healthcare professionals working with neonates should focus on pain management during heel pricks for two reasons. First, they are under an ethical obligation to help neonates experience as little pain as possible during medical procedures. Second, repeated painful exposure has harmful consequences. The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) also recommends pharmacological and non-pharmacological methods to prevent and effectively manage acute procedural pain in children. However, pharmacological methods for pain management in neonates may have some side effects. On the other hand, non-pharmacological methods are easy to use, affordable, and time-effective methods with no side effects. Healthcare professionals do not use non-pharmacological methods that are expensive, hard to apply, and time-consuming. Therefore, this study focused on maternal holding-cuddling and paternal holding-cuddling as alternative non-pharmacological methods to prevent procedural pain in neonates during heel pricks. Holding-cuddling is an effective non-pharmacological method for reducing procedural pain.
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?: