Leap Motion Controller for Pain During Venipuncture in Pediatrics

NCT ID: NCT05441241

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-10-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Leap Motion Controller

Group Type: EXPERIMENTAL

Leap Motion Controller

Intervention Type: 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

Standard care

Group Type: ACTIVE_COMPARATOR

Traditional distraction techniques

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

Traditional distraction techniques

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Egidio Barbi, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Locations

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

Trieste, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37773297 (View on PubMed)

Other Identifiers

RC 51/2022

Identifier Type: -

Identifier Source: org_study_id