Fundación Universitaria Sanitas
Bogotá, Bogota D.C., 111321, Colombia
NCT Number: NCT03985930
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.
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Notify Me3 year–5 year
All sexes
Interventional
Not applicable
Bogotá, Bogota D.C., 111321, Colombia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Distraction content delivered through virtual reality goggles
Treatment as Usual
Time frame: Immediately after procedure
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
Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2).
Time frame: Immediately after procedure
Subcomponent of the LLANTO scale scored as at ease or sleeping (0), restless (1), or agressive (2).
Time frame: Immediately after procedure
Subcomponent of the LLANTO scale scored normal (0), tachypneic (1), or irregular (2).
Time frame: Immediately after procedure
Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2).
Time frame: Immediately after procedure
Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2).
Time frame: During the statistical analysis stage
Between parents, nurse and physician
Claudia Aristizábal
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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