Non-immersive Virtual Reality for Pediatric Pain Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-immersive Virtual Reality for Pediatric Pain Management

Conditions
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Procedural Pain

Intervention / Treatment
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* Device: Distraction with virtual reality
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distraction Group<br>Children between the ages of 3 and 5 years will be distracted using virtual reality content delivered through goggles. | Device: Distraction with virtual reality<br>* Distraction content delivered through virtual reality goggles<br>|
| Active Comparator: Treatment as Usual<br>Children randomized to this group will receive the usual medical care. | Other: Treatment as Usual<br>* Treatment as Usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Preschool, Virtual Reality, Procedural Pain, Phlebotomy, Vaccination