Buzzy Distraction During Venipuncture

NCT02969902 | Completed

• 1 other identifier: RC 19/13
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Pain Relief

Keywords

Procedural pain; Phlebotomy; Distraction; Hand-held computer; Children

Outcome Measures

Primary Outcomes (1)

• Self-reported pain

  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.

  Within 5 minutes after the procedure

Secondary Outcomes (4)

• Pain evaluated by parents

  Within 5 minutes after the procedure

• Pain evaluated by nurses

  Within 5 minutes after the procedure

• Success at first attempt

  Intraprocedural

• Adverse events

  Up to 15 minutes after the procedure

Study Arms (2)

Buzzy® device

EXPERIMENTAL

The Buzzy® device is applied just above the selected site of the venipuncture; an ice pack is attached under the device; the device is turned on and after 15 second the venipuncture is made.

Device: Buzzy® device

Hand-held computer

ACTIVE COMPARATOR

Using an hand-held computer, children start to play with an age-appropriate videogame three minutes before the procedure. They continue to play during the venipuncture.

Device: Hand-held computer

Interventions

Buzzy® device DEVICE

Buzzy® device

Hand-held computer DEVICE

Hand-held computer

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children from 4 to 12 years of age needing venipuncture

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Egidio Barbi, MD

  IRCCS Burlo Garofolo

  STUDY CHAIR

• Franca Crevatin, RN

  IRCCS Burlo Garofolo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Epidemiology and Public Health Research Unit

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 21, 2017

Record last verified: 2017-08