Tablet Distraction for Pain Control During Venipuncture

Sponsor

IRCCS Burlo Garofolo (Other)

Overall Status

Completed

CT.gov ID

NCT02614391

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

66.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Relief	Other: Active distraction using a tablet Other: Passive distraction	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 13 Years

Sexes Eligible for Study:

All

Accepts 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