Leap Motion Controller for Pain During Venipuncture in Pediatrics

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05441241
Study type	Interventional
Source	IRCCS Burlo Garofolo
Contact
Status	Completed
Phase	N/A
Start date	July 1, 2022
Completion date	October 30, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04548635` - VR for Burn Dressing Changes at Home	Phase 2/Phase 3
Completed	`NCT00694174` - Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants	Phase 4
Completed	`NCT06264960` - The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography	N/A
Recruiting	`NCT06354608` - The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children	N/A
Completed	`NCT05073497` - Efficacy of Finger Puppet as a Distraction Method	N/A
Recruiting	`NCT05275881` - Impact of Virtual Reality in Pediatric Hematology and Oncology	N/A
Completed	`NCT04257019` - Pain, Anxiety During Interventional Spine Procedures	N/A
Completed	`NCT05656677` - Parental Involvement in Pain Reducing Measures	N/A
Completed	`NCT05166551` - Effect of Acupressure on Interventional Pain in Infants	N/A
Completed	`NCT04421430` - Nonpharmacological Methods for Children in Procedural Pain	N/A
Completed	`NCT06380556` - The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates	N/A
Not yet recruiting	`NCT05555498` - Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment	N/A
Completed	`NCT03985930` - Non-immersive Virtual Reality for Pediatric Pain Management	N/A
Completed	`NCT05070325` - Nonpharmacological Methods for Children	N/A
Completed	`NCT05179291` - Efficacy of VR and Buzzy on Pain and Anxiety	N/A
Completed	`NCT00150189` - Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations	N/A
Completed	`NCT04254081` - Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion	Phase 4
Recruiting	`NCT05895383` - Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy	Phase 4
Not yet recruiting	`NCT06373627` - Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease	N/A
Recruiting	`NCT04967118` - Neonatal Pain Management and Pain Monitoring Using New Methods	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Leap Motion Controller for Pain During Venipuncture in Pediatrics — LeapRCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms