Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED)

Study Overview
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Brief Summary
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The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test. Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. In the control group, the analysis will be done in the usual way (for example, distracting with questions) and in the intervention group, the analysis will be done while the children use virtual reality. The satisfaction of parents and nursing will also be analyzed.

Official Title
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Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial

Conditions
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Virtual Reality, Pediatric ALL, Pain, Procedural

Intervention / Treatment
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* Behavioral: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 7 and 12 years old who attend participating centers for scheduled blood tests. Consent to participate by signing the informed consent. Exclusion Criteria: Children younger than 7 years old. Children older than 12 years old. Children that don't sign the informed consent. Children with psychomotor and neurocognitive delay. Children with visual or hearing impairment.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized in a 1:1 ratio to the intervention group (use of virtual reality during blood collection) and the control group (usual care). The randomization sequence is different for each participating center.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>In this arm, the analysis will be done in the usual way (for example, distracting with questions). | |
| Active Comparator: Virtual reality<br>In this arm, the analysis will be done while the children use virtual reality. | Behavioral: Virtual reality<br>* In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain associated with venipuncture | Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain. | 1 day: The day of the venipuncture | 
| Anxiety | Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient. | 1 day: The day of the venipuncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts for analytics | 1, 2, 3, 4, or 5 | 1 day: The day of the venipuncture | 
| Time required for analysis | Minutes | 1 day: The day of the venipuncture | 
| Difficulty level of the technique | Easy, normal or difficult | 1 day: The day of the venipuncture | 
| Parents satisfaction | 1 = unsatisfied 10 = very satisfied | 1 day: The day of the venipuncture | 
| Nurse anxiety | 1 = totally calm 10 = very anxious | 1 day: The day of the venipuncture |