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Leap Motion Controller for Pain During Venipuncture in Pediatrics (LeapRCT)

I

IRCCS Burlo Garofolo

Status

Completed

Conditions

Procedural Pain
Venipuncture

Treatments

Device: Leap Motion Controller
Other: Traditional distraction techniques

Study type

Interventional

Funder types

Other

Identifiers

NCT05441241
RC 51/2022

Details and patient eligibility

About

Venipuncture is the most frequent invasive procedure in hospitals and clinics. In the pediatric population this is very often associated with fear, anxiety, distress and enhanced perception of pain. Local anesthetic creams (like EMLA) are used to reduce pain and distress but they need 30-60 minutes of waiting between the application and the puncture, which is too much time for most of everyday life clinical contests. Many distraction techniques have been studied, both active (ie video games, virtual reality) and passive (ie listening to music, visual stimulation).

Active production of music is one of the most complex activities for our central nervous system. It requires a precise timing of a lot of well-coordinated actions, like recognition and conservation of a rhythmic structure, precise execution of quick and complex fine movements, and with an important involvement of intense emotional experience. It stimulates bilaterally primary and secondary auditory cerebral areas, but also motor and premotor areas, language areas and their contralateral, cognitive areas. At the same time, it activates reward and gratification circuits with stimulation of the limbic system and endorphin release and also neurovegetative system. Music is probably the most immediate and spontaneous communication tool that can also act at subcortical level without the person being aware of what they are receiving and transmitting. Music activates the dopaminergic mesolimbic system, which regulates memory, attention, executive functions, motivation and also mood and pleasure through the nucleus accumbens. It also produces measurable cardiovascular and endocrine responses indicated by reduced serum cortisol levels and inhibition of cardiovascular stress reactions.

The Leap Motion Controller is an infrared device that digitalizes the movements of the hand above it in real-time: this is connected with a software that converts this signal into a musical tone specifically set. The melody is created very easily just by moving the hand above it. With this device, children will be able to produce music without anything interposing between them and the sound production. This will allow the patient to focus only on the melodies, without technical difficulties that could derive for instance from a visual interface or an instrument you have to hold.

Enrollment

300 patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children aged 8-17 years undergoing venipuncture

Exclusion criteria

  • Patients with cognitive impairment
  • Patients who do not understand the Italian language or with parents who are unable to provide a written informed consent in Italian language
  • Patients medicated with local anaesthetic cream

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Leap Motion Controller
Experimental group
Treatment:
Device: Leap Motion Controller
Standard care
Active Comparator group
Treatment:
Other: Traditional distraction techniques

Trial contacts and locations

1

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Central trial contact

Egidio Barbi, MD; Giorgio Cozzi, MD

Data sourced from clinicaltrials.gov

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