Viewing Study NCT06566378



Ignite Creation Date: 2024-10-26 @ 3:38 PM
Last Modification Date: 2024-10-26 @ 3:38 PM
Study NCT ID: NCT06566378
Status: RECRUITING
Last Update Posted: None
First Post: 2024-08-20

Brief Title: Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children
Sponsor: None
Organization: None

Study Overview

Official Title: The Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children A Randomized Controlled Study
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study was designed as a randomized controlled experimental research with the purpose of determining the effect of using Cold Application and Vibration in reducing pain during routine vaccination in children
Detailed Description: In the literature it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on painIn light of this information this study aimed to examine the effect of by using Cold Application and Vibration in reducing pain during routine vaccination in children Cold Application and Vibration will be done with BUZZY

This study is a prospective randomized and controlled trial Children aged 13 years who required routine vaccination were divided into three groups placed under arm Buzzy placed in standard Buzzy and Control Data were obtained through face-to-face interviews with the children their parents and the observer before and after the procedure The childrens pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES

The study population consisted of the childrens during routine vaccination in children aged 13 years Sample of the study consisted of a total of 90 children who met the sample selection criteria and were selected via randomization method

Children were randomized into three groups placed under arm Buzzy n30 placed in standard Buzzy n30 and Control n30 Data were collected using the Interview and Observation Form and Wong-Baker FACES Pain Rating Scale

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None