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Tablet Distraction for Pain Control During Venipuncture

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02614391
Enrollment
200
Registered
2015-11-25
Start date
2013-03-31
Completion date
2013-06-30
Last updated
2015-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Relief

Keywords

Procedural pain, Phlebotomy, Distraction, Videogame, Computer tablet, Child

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.

Interventions

OTHERActive distraction using a tablet

Playing a videogame using a computer tablet

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

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Success at first attemptIntraprocedural (an average of 5 minutes)Percentage of success at first attempt
Adverse eventsUp to 15 minutes after the procedureThe number and the type of adverse events will be recorded

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026