Tablet Distraction for Pain Control During Venipuncture

I

IRCCS Burlo Garofolo

Status and phase

Completed
Phase 3

Conditions

Pain Relief

Treatments

Other: Passive distraction
Other: Active distraction using a tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT02614391
RC 38/12

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

4 to 13 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Active distraction using a tablet
Experimental group
Description:
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.
Treatment:
Other: Active distraction using a tablet
Passive distracion
Active Comparator group
Description:
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.
Treatment:
Other: Passive distraction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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