Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Infants During Vaccination
Sponsor:
Istanbul Medeniyet University
Organization:
Istanbul Medeniyet University
Study Overview
Official Title:
The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Healthy Infants During Intramuscular Vaccination A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 conducted to determine the effect of mechanical vibration and Helfer Skin Tap technique applied during intramuscular Hepatitis B vaccination on procedural pain level crying time and procedure time in healthy infants
Detailed Description:
Hepatitis B vaccination is one of the painful procedures routinely performed in infants The pain experienced by the infant 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 infants frequently encounter Mechanical vibration and Helfer skin tap technique are effective methods that can be used in nonpharmacologic procedural pain management
Studies have commonly used parent-related methods kangaroo care mother father 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 needle related acute pain In addition no study was found in the literature comparing the effect of mechanical vibration and Helfer skin tap technique on hepatitis B vaccination-related pain This study will be investigated the effects of mechanical vibration and Helfer skin tap technique methods on procedural pain crying time and duration of the procedure during intramuscular Hepatitis B vaccination in healthy term infants
Studies have commonly used parent-related methods kangaroo care mother father 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 needle related acute pain In addition no study was found in the literature comparing the effect of mechanical vibration and Helfer skin tap technique on hepatitis B vaccination-related pain This study will be investigated the effects of mechanical vibration and Helfer skin tap technique methods on procedural pain crying time and duration of the procedure during intramuscular Hepatitis B vaccination 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