Non-immersive Virtual Reality for Pediatric Pain Management
Study Details
Study Description
Brief 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 (<6 years) pain associated with venipuncture, intramuscular injection, and vaccination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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: Assess the effect on pain of distraction with virtual reality or video projections during procedures of venipuncture, administration of intramuscular medication and vaccination to children under 6 years of age.
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 either video projections or virtual reality. Children in the experimental group between 12 months and 3 years of age will be distracted using video projections, and those between 3 and 6 years of age 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.
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Distraction Group Children between the ages of 3 and 6 years will be distracted using virtual reality content delivered through goggles. Since exposure to video screens has been previously discouraged by various scientific and professional medical organizations in children under 3 years of age, these children will be distracted using video projections of the same content. |
Other: Distraction with virtual reality or video projection
Distraction content delivered through virtual reality goggles or video projection.
|
| Active Comparator: Treatment as Usual Children randomized to this group will receive the usual medical care. |
Other: Distraction with virtual reality or video projection
Distraction content delivered through virtual reality goggles or video projection.
|
Outcome Measures
Primary Outcome Measures
- LLANTO Pain level: LLANTO pain scale [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
Secondary Outcome Measures
- LLANTO Crying [Immediately after procedure]
Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2).
- LLANTO Attitude [Immediately after procedure]
Subcomponent of the LLANTO scale scored as at ease or sleeping (0), restless (1), or agressive (2).
- LLANTO Breathing [Immediately after procedure]
Subcomponent of the LLANTO scale scored normal (0), tachypneic (1), or irregular (2).
- LLANTO Facial expression [Immediately after procedure]
Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2).
- LLANTO Postural muscle tone [Immediately after procedure]
Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fundación Universitaria Sanitas | Bogotá | Bogotá D.C. | Colombia | 111321 |
Sponsors and Collaborators
- Claudia Aristizábal
- Sanitas University
Investigators
- Principal Investigator: Jhon H Camacho Cruz, M.D., Fundación Universitaria Sanitas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VRPedPain