LeapRCT: Leap Motion Controller for Pain During Venipuncture in Pediatrics
Study Details
Study Description
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.
It is well known that we can use local anaesthetic creams (like EMLA) to reduce pain and therefore 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, for instance in the emergency department.
Many distraction techniques have been studied: active- (video games, virtual reality, interactive games…) and passive ones (listening to music, visual stimulation, lecture…), some of them with a high-tech device, others with a low-tech device, but the quality of most of these trials is quite low. It is useful to have studies in which traditional distraction techniques are compared with experimental techniques, while keeping in mind the practicality of them in real contests.
Active production of music, both in a musician and in a non-musician, 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. In fact it stimulates bilaterally primary and secondary auditory cerebral areas, but also motor and premotor areas, language areas and their controlateral, 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. In particular 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 experimental technique we suggest uses the Leap Motion Controller, that 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
| Active Comparator: Standard care
|
Other: Traditional distraction techniques
Common distraction techniques will be used (i.e., visual stimulation, lecture)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Children aged 8-17 years undergoing venipuncture
Exclusion Criteria:
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Patients with cognitive impairment
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Patients who do not understand the Italian language or with parents who are unable to provide a written informed consent in Italian language
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Patients medicated with local anaesthetic cream
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" | Trieste | Italy | 34137 |
Sponsors and Collaborators
- IRCCS Burlo Garofolo
Investigators
- Principal Investigator: Egidio Barbi, MD, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC 51/2022