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Clinical Trial Summary

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using external cold and vibration-Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy injection.

Clinical Trial 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 pain. In light of this information, this study aimed to compare the effect of distraction by using Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy. This study is a prospective, randomized and controlled trial. Children aged 7 to 12 years who required phlebotomy were divided into three groups; buzzy, virtual reality, and controls. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale. The study population consisted of children aged 7 to 12 years who presented to the children's phlebotomy room of the hospital. Sample of the study consisted of a total of 120 children who met the sample selection criteria and were selected via randomization method. Children were randomized into three groups: Buzzy (n= 40), VR group (n= 40), and the control group (n= 40). Data were collected using the Information Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05179291
Study type Interventional
Source Bandirma Onyedi Eylül University
Status Completed
Phase N/A
Start date November 1, 2017
Completion date August 31, 2018

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