Clinical trial NCT05441241: Leap Motion Controller for Pain During Venipuncture in Pediatrics
Official title: Reduction of Pain and Distress in Pediatric Population Undergoing a Venipuncture With Active Production of Music With the Leap Motion Controller - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Venipuncture
Keywords: Procedural Pain
Venipuncture
Children, Distraction
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in procedural pain score between experimental and control group
timeFrame: 1 minutes after the procedure
Secondary outcomes:
measure: Difference in child distress between experimental and control group evaluated by parents
timeFrame: 1 minutes before the procedure
measure: Difference in child distress between experimental and control group evaluated by health operators
timeFrame: 1 minutes before the procedure
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Egidio Barbi, MD
role: PRINCIPAL_INVESTIGATOR
References: