Buzzy Distraction During Venipuncture

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain Relief

Intervention / Treatment
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* Device: Buzzy® device
* Device: Hand-held computer


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buzzy® device<br>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<br> <br> |
| Active Comparator: Hand-held computer<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procedural pain, Phlebotomy, Distraction, Hand-held computer, Children