An interventional study of Leap Motion Controller and Traditional distraction techniques in Procedural Pain and Venipuncture, sponsored by IRCCS Burlo Garofolo. Completed at 1 site in Italy. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by IRCCS Burlo Garofolo · Not applicable, Interventional, and Supportive care
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.
237 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 300 is above the median of 83 across 223 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →IRCCS Burlo Garofolo is the lead sponsor of 87 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Device: Leap Motion Controller
Other: Traditional distraction techniques
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
Common distraction techniques will be used (i.e., visual stimulation, lecture)
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).
Time frame: 1 minutes after the procedure
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.
Time frame: 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.
Time frame: 1 minutes before the procedure
Plan to share: Undecided
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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IRCCS Burlo Garofolo