Procedural Pain
Conditions
Keywords
Child, Preschool, Virtual Reality, Procedural Pain, Phlebotomy, Vaccination
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 (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.
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: 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.
Interventions
Distraction content delivered through virtual reality goggles
OTHERTreatment as Usual
Treatment as Usual
Sponsors
Sanitas University
Claudia Aristizábal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Crying | Immediately after procedure | Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2). |
| LLANTO Postural muscle tone | Immediately after procedure | Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2). |
| Interrater reliability of the LLANTO scale | During the statistical analysis stage | Between parents, nurse and physician |
| LLANTO Facial expression | Immediately after procedure | Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2). |
Countries
Colombia
Outcome results
None listed