NCT02614391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

November 23, 2015

Last Update Submit

November 27, 2015

Conditions

Pain Relief

Keywords

Procedural painPhlebotomyDistractionVideogameComputer tabletChild

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Success at first attempt

    Intraprocedural (an average of 5 minutes)

  • Adverse events

    Up to 15 minutes after the procedure

Study Arms (2)

Active distraction using a tablet

EXPERIMENTAL

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

Passive distracion

ACTIVE COMPARATOR

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

Interventions

Active distraction using a tabletOTHER

Playing a videogame using a computer tablet

Active distraction using a tablet
Passive distractionOTHER

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

Passive distracion

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 4 to 13 years
  • Need for venipuncture
  • Informed consent signed by parents or legal guardians

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Franca Crevatin, RN

    IRCCS Burlo Garofolo

    STUDY CHAIR

  • Franca Crevatin, RN

    IRCCS Burlo Garofolo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 25, 2015

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations

IT(1)