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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Distraction content delivered through virtual reality goggles
Treatment as Usual
Fundación Universitaria Sanitas
Bogotá, Bogota D.C., Colombia
LLANTO Pain level: LLANTO pain scale
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
Time frame: Immediately after procedure
LLANTO Crying
Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2).
Time frame: Immediately after procedure
LLANTO Attitude
Subcomponent of the LLANTO scale scored as at ease or sleeping (0), restless (1), or agressive (2).
Time frame: Immediately after procedure
LLANTO Breathing
Subcomponent of the LLANTO scale scored normal (0), tachypneic (1), or irregular (2).
Time frame: Immediately after procedure
LLANTO Facial expression
Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2).
Time frame: Immediately after procedure
LLANTO Postural muscle tone
Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2).
Time frame: Immediately after procedure
Interrater reliability of the LLANTO scale
Between parents, nurse and physician
Time frame: During the statistical analysis stage
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