Tablet Distraction for Pain Control During Venipuncture

Pain Relief Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614391
• Other study ID #: RC 38/12
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2015
• Last updated: November 27, 2015
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: November 2015
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 13 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain Relief

Intervention

Other:
• Active distraction using a tablet
Playing a videogame using a computer tablet
• Passive distraction
A nurses singing a song, reading a book, blowing bubbles and playing a puppet show

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Success at first attempt	Percentage of success at first attempt	Intraprocedural (an average of 5 minutes)	No
Secondary	Adverse events	The number and the type of adverse events will be recorded	Up to 15 minutes after the procedure	No