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| Name | Class |
|---|---|
| Sanitas University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distraction Group | Experimental | Children between the ages of 3 and 5 years will be distracted using virtual reality content delivered through goggles. |
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| Treatment as Usual | Active Comparator | Children randomized to this group will receive the usual medical care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distraction with virtual reality | Device | Distraction content delivered through virtual reality goggles |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| LLANTO Crying | Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2). | Immediately after procedure |
| LLANTO Attitude | Subcomponent of the LLANTO scale scored as at ease or sleeping (0), restless (1), or agressive (2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jhon H Camacho Cruz, M.D. | Fundación Universitaria Sanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Universitaria Sanitas | Bogotá | Bogota D.C. | 111321 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407711 | Derived | Camacho-Cruz J, Palacios-Ariza MA, Orrego-Celestino L, Valbuena-Velandia N, Paez-Castellanos L, Bolanos JM, Pradilla I. Effectiveness of non-immersive virtual reality in the management of procedure-related pain in preschool children: a randomized clinical trial. Eur J Pediatr. 2023 Sep;182(9):4103-4112. doi: 10.1007/s00431-023-05070-5. Epub 2023 Jul 5. |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual | Other | Treatment as Usual |
|
| Immediately after procedure |
| LLANTO Breathing | Subcomponent of the LLANTO scale scored normal (0), tachypneic (1), or irregular (2). | Immediately after procedure |
| LLANTO Facial expression | Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2). | Immediately after procedure |
| LLANTO Postural muscle tone | Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2). | Immediately after procedure |
| Interrater reliability of the LLANTO scale | Between parents, nurse and physician | During the statistical analysis stage |