Leap Motion Controller for Pain During Venipuncture in Pediatrics

NCT05441241 | Completed

• 1 other identifier: RC 51/2022
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain; Venipuncture

Keywords

Procedural Pain; Venipuncture; Children, Distraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in child distress between experimental and control group evaluated by parents

  1 minutes before the procedure

• Difference in child distress between experimental and control group evaluated by health operators

  1 minutes before the procedure

Study Arms (2)

Leap Motion Controller

EXPERIMENTAL

Device: Leap Motion Controller

Standard care

ACTIVE COMPARATOR

Other: Traditional distraction techniques

Interventions

Leap Motion Controller DEVICE

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

Leap Motion Controller

Traditional distraction techniques OTHER

Common distraction techniques will be used (i.e., visual stimulation, lecture)

Standard care

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 8-17 years undergoing venipuncture

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

Location

Related Publications (1)

• Obersnel M, Nardin B, Canepari E, Torelli L, Rizzitelli P, Buchini S, Schreiber S, Barbi E, Cozzi G. Active production of music as distraction for venipuncture in children and adolescents: a randomized clinical trial. Eur J Pediatr. 2023 Dec;182(12):5455-5463. doi: 10.1007/s00431-023-05227-2. Epub 2023 Sep 29.

  PMID: 37773297 DERIVED

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Egidio Barbi, MD

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: July 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

IT (1)