Leap Motion Controller for Pain During Venipuncture in Pediatrics

Not Applicable

Completed

• Conditions: Procedural Pain; Venipuncture
• Interventions: Other: Traditional distraction techniques; Device: Leap Motion Controller

• Registration Number: NCT05441241
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-28
• Study Start: 2022-07-01
• Study First Posted: 2022-07-01
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Traditional distraction techniques	-
Leap Motion Controller	Leap Motion Controller	-

Primary Outcome Measures

Name	Time	Method
Difference in procedural pain score between experimental and control group	1 minutes after the procedure	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).

Secondary Outcome Measures

Name	Time	Method
Difference in child distress between experimental and control group evaluated by parents	1 minutes before the procedure	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.
Difference in child distress between experimental and control group evaluated by health operators	1 minutes before the procedure	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.

Trial Locations

Locations (1)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"; 🇮🇹 Trieste, Italy