Clinical Trials Directory

Trials / Completed

CompletedNCT02969902

Buzzy Distraction During Venipuncture

Randomized Controlled Trial to Compare Buzzy and Hand-held Computer Distraction for Pain Control in Children Underwent Venipuncture.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (actual)
Sponsor
IRCCS Burlo Garofolo · Academic / Other
Sex
All
Age
4 Years – 12 Years
Healthy volunteers
Not accepted

Summary

Venipuncture is one of the most common iatrogenic painful and stressful procedures performed on children. Interventions aimed at reducing the distress related to this experience are widely and strongly recommended. Pain and anxiety management is even more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture related pain and distress, with a strong evidence supporting its efficacy in children and adolescents. In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines distraction and physical analgesia (vibration and cold) and it was positively tested during venipuncture, intravenous cannulation and painful injections in children. Even though its efficacy it's well established, most of the published trials did not compare Buzzy with other interventions, so that little data are available about its usefulness compared with other distractions techniques. Hand-held computers are reusable tools, which offer a technological-based active distraction. There is evidence supporting their used during painful procedures such as venipuncture and a recent published study showed that hand-held computer distraction was as effective as nurse-led passive distraction techniques in children. The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in pain relief during venipuncture.

Conditions

Interventions

TypeNameDescription
DEVICEBuzzy® device
DEVICEHand-held computer

Timeline

Start date
2014-11-01
Primary completion
2015-02-01
Completion
2015-02-01
First posted
2016-11-21
Last updated
2017-08-21

Source: ClinicalTrials.gov record NCT02969902. Inclusion in this directory is not an endorsement.