Tablet Distraction for Pain Control During Venipuncture

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain Relief

Intervention / Treatment
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* Other: Active distraction using a tablet
* Other: Passive distraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active distraction using a tablet<br>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<br>* Playing a videogame using a computer tablet<br>|
| Active Comparator: Passive distracion<br>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<br>* A nurses singing a song, reading a book, blowing bubbles and playing a puppet show<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success at first attempt | Percentage of success at first attempt | Intraprocedural (an average of 5 minutes) | 
| Adverse events | The number and the type of adverse events will be recorded | Up to 15 minutes after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procedural pain, Phlebotomy, Distraction, Videogame, Computer tablet, Child