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Clinical Trials/NCT05441241
NCT05441241
Completed
N/A

Reduction of Pain and Distress in Pediatric Population Undergoing a Venipuncture With Active Production of Music With the Leap Motion Controller - a Randomized Controlled Trial

IRCCS Burlo Garofolo1 site in 1 country300 target enrollmentJuly 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Procedural Pain
Sponsor
IRCCS Burlo Garofolo
Enrollment
300
Locations
1
Primary Endpoint
Difference in procedural pain score between experimental and control group
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
October 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
IRCCS Burlo Garofolo
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Difference in procedural pain score between experimental and control group

Time Frame: 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 Outcomes

  • 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 Sites (1)

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