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OpenTrials
Completed

NCT Number: NCT02969902

Buzzy Distraction During Venipuncture

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children from 4 to 12 years of age needing venipuncture

Exclusion criteria

  • the presence of damage, denuded or broken skin in the site of Buzzy application;
  • use of topical, enteral or parenteral analgesics within eight hours before enrolment;
  • the presence of cognitive impairment or the inability to report pain verbally;
  • the presence of chronic disease, included epilepsy, or of diseases associated with cold hypersensitivity (i.e., sickle cell anaemia, Raynaud's disease).

Treatment and study plan

Buzzy® device

Device

Hand-held computer

Device

Primary outcomes

  1. Self-reported pain

    Time frame: Within 5 minutes after the procedure

    Children from 4 to 7 years of age record their pain using the Faces Pain Scale-Revised (FPS-R); children from 8 to 12 years using a Numerical Rating Scale, with scores from zero to 10.

Secondary outcomes

  1. Pain evaluated by parents

    Time frame: Within 5 minutes after the procedure

    Pain evaluated using a Numerical Rating Scale, with scores from zero to 10

  2. Pain evaluated by nurses

    Time frame: Within 5 minutes after the procedure

    Pain evaluated using a Numerical Rating Scale, with scores from zero to 10

  3. Success at first attempt

    Time frame: Intraprocedural

    Percentage of success at first attempt

  4. Adverse events

    Time frame: Up to 15 minutes after the procedure

    The number and the type of adverse events

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2016
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.