Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377748
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-04-17
Brief Title:
The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants
Sponsor:
Istanbul Medeniyet University
Organization:
Istanbul Medeniyet University
Study Overview
Official Title:
The Effect of Facilitated-tucking ShotBlocker and the Combination of the Facilitated-tucking and ShotBlocker on Pain Caused by Hepatitis-B Vaccination in Healthy Term Infants Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-10
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 will be investigated the effects of facilitated tucking ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants
Detailed Description:
Hepatitis B vaccination is one of the painful procedures routinely performed in newborns The pain experienced by the newborn negatively affects the prognosis of the disease the infants behavior the harmony with the environment the development of the brain and senses as well as the family-infant interaction Nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that newborns frequently encounter Facilitated tucking and ShotBlocker are effective methods that can be used in nonpharmacologic procedural pain management
Studies have commonly used parent-related methods kangaroo care motherfather cuddling breastfeeding etc for neonatal pain management during Hepatitis B vaccine administration In units where access to the parent is not always possible nonpharmacologic pain methods that can be used independently of the parent can be used in the management of acute needle-related pain In addition no study was found in the literature comparing and combining the effect of fetal position and ShotBlocker application on hepatitis B vaccine-related pain This study will be investigated the effects of facilitated tucking ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants
Studies have commonly used parent-related methods kangaroo care motherfather cuddling breastfeeding etc for neonatal pain management during Hepatitis B vaccine administration In units where access to the parent is not always possible nonpharmacologic pain methods that can be used independently of the parent can be used in the management of acute needle-related pain In addition no study was found in the literature comparing and combining the effect of fetal position and ShotBlocker application on hepatitis B vaccine-related pain This study will be investigated the effects of facilitated tucking ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants
Study Oversight
Has Oversight DMC:
None
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?:
None