Non-immersive Virtual Reality for Pediatric Pain Management

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.

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.

Children between the ages of 3 and 5 years will be distracted using virtual reality content delivered through goggles.

Overall pain assessment using the LLANTO pain scale (Mild: 0-3, Moderate 4-6, Intense 7-10) For more information about LLANTO scale, please visit DOI: 10.1016/j.anpedi.2010.08.005

Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2).

Inclusion Criteria: Patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers. Exclusion Criteria: Fever (Axillary temperature greater than 38°C). Systemic Inflammatory Response Syndrome or Sepsis. Pulmonary disease. Neurological deficit of any kind. Susspected or confirmed metabolic disease. Undernutrition or obesity as defined by deviations from the mean of local values.