Randomized Controlled Trial to Evaluate Tablet Distraction for Pain Control in Children Underwent Venipuncture
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- IRCCS Burlo Garofolo
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Pain score recorded by the Faces Pain Scale-Revised (FPS-R)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 13 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Pain score recorded by the Faces Pain Scale-Revised (FPS-R)
Time Frame: Intraprocedural (an average of 5 minutes)
The pain during the procedure will be evaluated using the self-reported FPS-R scale
Secondary Outcomes
- Success at first attempt(Intraprocedural (an average of 5 minutes))
- Adverse events(Up to 15 minutes after the procedure)
Investigators
Ronfani Luca
MD, PhD
IRCCS Burlo Garofolo