Clinical trial NCT02969902: Buzzy Distraction During Venipuncture
Official title: Randomized Controlled Trial to Compare Buzzy and Hand-held Computer Distraction for Pain Control in Children Underwent Venipuncture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Relief
Keywords: Procedural pain
Phlebotomy
Distraction
Hand-held computer
Children
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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).

Primary outcomes:
measure: Self-reported pain
timeFrame: Within 5 minutes after the procedure
Secondary outcomes:
measure: Pain evaluated by parents
timeFrame: Within 5 minutes after the procedure
measure: Pain evaluated by nurses
timeFrame: Within 5 minutes after the procedure
measure: Success at first attempt
timeFrame: Intraprocedural
measure: Adverse events
timeFrame: Up to 15 minutes after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Egidio Barbi, MD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo
name: Franca Crevatin, RN
role: STUDY_DIRECTOR
References: