Tablet Distraction for Pain Control During Venipuncture

Phase 3

Completed

• Conditions: Pain Relief

• Registration Number: NCT02614391
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

Venipuncture is one of the painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted.

The base for pain management starts with behavioural and environmental support and distraction. Distraction is a cognitive strategy trying to divert the child's attention from a noxious stimulus. Active distraction involves the child in a different performance, e.g. playing, during pain procedures. Passive distraction redirects the child's attention to visual or auditory stimuli using toys, songs, movies or blowing bubbles.

Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a limited time. Patients usually arrive without a pharmacological premedication and go away immediately after procedure. In this context distraction is an excellent pain relief tool.

The aim of the study is to compare the effectiveness of an active distraction (playing a videogame using a computer tablet) with a passive distraction technique in pain relief during venipuncture in a blood-drawing centre.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-11
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 4 to 13 years
• Need for venipuncture
• Informed consent signed by parents or legal guardians

Exclusion Criteria

• Children with epilepsy
• Use of topical, enteral or parenteral analgesics within 8 hours before the procedure
• Inability to perform venipuncture on hand or arm
• Children with cognitive impairment or unable to report their pain verbally

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score recorded by the Faces Pain Scale-Revised (FPS-R)	Intraprocedural (an average of 5 minutes)	The pain during the procedure will be evaluated using the self-reported FPS-R scale

Secondary Outcome Measures

Name	Time	Method
Success at first attempt	Intraprocedural (an average of 5 minutes)	Percentage of success at first attempt
Adverse events	Up to 15 minutes after the procedure	The number and the type of adverse events will be recorded

Trial Locations

Locations (1)

IRCCS Burlo Garofolo; 🇮🇹 Trieste, Friuli Venezia Giulia, Italy