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

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

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.

Study Overview

• Status: Completed
• Conditions: Procedural Pain; Venipuncture
• Intervention / Treatment: Device: Leap Motion Controller; Other: Traditional distraction techniques

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giorgio Cozzi, MD; Email: giorgio.cozzi@burlo.trieste.it

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care	Other: Traditional distraction techniques; Common distraction techniques will be used (i.e., visual stimulation, lecture)
Experimental: Leap Motion Controller	Device: Leap Motion Controller; The Leap Motion Controller is an infrared device that digitalizes in real-time the movements of the hand above it. This signal will be converted into Musical Instrument Digital Interface (MIDI) and then translated into a sound of a pitch that depends on the distance between the hand and the device. The software is set to produce a pentatonic scale, so every melody created by the patient will sound consonant, and the timbre will be warm, calm and in human vocal range (similar to a cello). The operator will do an example, playing a melody, and will invite the patient to imitate him. When the patient gains confidence with the device, after a limited time lapse (from 30 seconds to 3 minutes), while they are playing it with one hand, the venipuncture is done on the other arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in procedural pain score between experimental and control group	Procedural pain self-reported by children using the Faces Pain Scale Revised (FPS-R scale). The FPS-R algometric scale includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).	1 minutes after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in child distress between experimental and control group evaluated by parents	The distress score will be evaluated by parents through the Distress thermometer, a single-item tool using a 0 (no distress) to 10 (extreme distress)-point Likert scale resembling a thermometer.	1 minutes before the procedure
Difference in child distress between experimental and control group evaluated by health operators	The distress score will be evaluated by health operators through the Distress thermometer, a single-item tool using a 0 (no distress) to 10 (extreme distress)-point Likert scale resembling a thermometer.	1 minutes before the procedure

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Principal Investigator: Egidio Barbi, MD, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Venipuncture; Procedural Pain; Children, Distraction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural
• Other Study ID Numbers: RC 51/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No