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OpenTrials
Completed

NCT Number: NCT02614391

Tablet Distraction for Pain Control During 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.

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Key information

Conditions

Pain Relief Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active distraction using a tablet

Other

Playing a videogame using a computer tablet

Passive distraction

Other

A nurses singing a song, reading a book, blowing bubbles and playing a puppet show

Primary outcomes

  1. Pain score recorded by the Faces Pain Scale-Revised (FPS-R)

    Time frame: Intraprocedural (an average of 5 minutes)

    The pain during the procedure will be evaluated using the self-reported FPS-R scale

Secondary outcomes

  1. Success at first attempt

    Time frame: Intraprocedural (an average of 5 minutes)

    Percentage of success at first attempt

  2. Adverse events

    Time frame: Up to 15 minutes after the procedure

    The number and the type of adverse events will be recorded

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 25, 2015
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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