NCT03985930

Non-immersive Virtual Reality for Pediatric Pain Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Claudia Aristizábal · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.

Detailed description

Background: Recent studies have shown that the use of virtual reality (VR) may be useful to provide distraction that attenuates pain in minimally invasive procedures in preschool children. Aim: To assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 to 5 years undergoing painful injection procedures in an outpatient setting. Method: This clinical trial will recruit patients under 6 years of age treated at participating medical centers in whom a painful procedure like vaccination, venipuncture or administration of intramuscular medication will be performed. The experimental group will consist of two subgroups which, in addition to treatment as usual, will be distracted using virtual reality content delivered through goggles. The control group will receive treatment as usual. The LLANTO pain scale will be used to measure different characteristics of pain. This scale has been validated in Colombia, and will be filled by two health professionals (one of which will perform the painful procedure.) and the parents. Expected results: To show that virtual reality or projector distraction are effective distraction tools in pain management for children subjected to painful procedures of venipuncture, intramuscular medication administration, and vaccination.

Conditions

• Procedural Pain

Interventions

Type	Name	Description
DEVICE	Distraction with virtual reality	Distraction content delivered through virtual reality goggles
OTHER	Treatment as Usual	Treatment as Usual

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2019-06-14
• Last updated: 2023-04-03

Locations

1 site across 1 country: Colombia