Buzzy Distraction During Venipuncture

Pain Relief Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969902
• Other study ID #: RC 19/13
• Status: Completed
• Phase: N/A
• First received: November 17, 2016
• Last updated: August 16, 2017
• Start date: November 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2017
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain Relief

Intervention

Device:
• Buzzy® device

• Hand-held computer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain evaluated by parents	Pain evaluated using a Numerical Rating Scale, with scores from zero to 10	Within 5 minutes after the procedure
Secondary	Pain evaluated by nurses	Pain evaluated using a Numerical Rating Scale, with scores from zero to 10	Within 5 minutes after the procedure
Secondary	Success at first attempt	Percentage of success at first attempt	Intraprocedural
Secondary	Adverse events	The number and the type of adverse events	Up to 15 minutes after the procedure