Buzzy Distraction During Venipuncture

IRCCS Burlo Garofolo

Status: Completed

Conditions: Pain Relief

Treatments: Device: Hand-held computer; Device: Buzzy® device

Study type: Interventional

Funder types: Other

Identifiers

NCT02969902

RC 19/13

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Buzzy® device

Experimental group

Description:

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.

Treatment:

Device: Buzzy® device

Hand-held computer

Active Comparator group

Description:

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.

Treatment:

Device: Hand-held computer