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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy® device | Device |
| ||
| Hand-held computer |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Egidio Barbi, MD | IRCCS Burlo Garofolo | Study Chair |
| Franca Crevatin, RN | IRCCS Burlo Garofolo | Study Director |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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 |