Tablet Distraction for Pain Control During Venipuncture

Randomized Controlled Trial to Evaluate Tablet Distraction for Pain Control in Children Underwent Venipuncture

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.

Study Overview

• Status: Completed
• Conditions: Pain Relief
• Intervention / Treatment: Other: Active distraction using a tablet; Other: Passive distraction

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34137
      • IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active distraction using a tablet; Children were admitted in a comfortable room with a parent and started to play with a videogame suitable for their age three minutes before procedure. They continued to play the videogame during venipuncture. The use of a computer tablet permitted to play with one hand only.	Other: Active distraction using a tablet; Playing a videogame using a computer tablet
Active Comparator: Passive distracion; Children were admitted in a comfortable room with a parent and received various kinds of passive distractions: nurses singing a song, reading a book, blowing bubbles and playing a puppet show. The technique that most engaged the child, was continued during procedure.	Other: Passive distraction; A nurses singing a song, reading a book, blowing bubbles and playing a puppet show

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Franca Crevatin, RN, IRCCS Burlo Garofolo; Principal Investigator: Franca Crevatin, RN, IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 27, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Child; Procedural pain; Phlebotomy; Distraction; Videogame; Computer tablet
• Other Study ID Numbers: RC 38/12