Buzzy Distraction During Venipuncture

NCT ID: NCT02969902

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Buzzy® device

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.

Group Type: EXPERIMENTAL

Buzzy® device

Intervention Type: DEVICE

Hand-held computer

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.

Group Type: ACTIVE_COMPARATOR

Hand-held computer

Intervention Type: DEVICE

Interventions

Buzzy® device

Intervention Type: DEVICE

Hand-held computer

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Luca Ronfani

Head of Clinical Epidemiology and Public Health Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Egidio Barbi, MD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo

Franca Crevatin, RN

Role: STUDY_DIRECTOR

IRCCS Burlo Garofolo

Other Identifiers

RC 19/13

Identifier Type: -

Identifier Source: org_study_id