Non-immersive Virtual Reality for Pediatric Pain Management

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.

Study Overview

• Status: Completed
• Conditions: Procedural Pain
• Intervention / Treatment: Device: Distraction with virtual reality; Other: Treatment as Usual

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá D.C.
    • Bogotá, Bogotá D.C., Colombia, 111321
      • Fundación Universitaria Sanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Claudia Aristizábal
• Collaborators: Sanitas University
• Investigators: Principal Investigator: Jhon H Camacho Cruz, M.D., Fundación Universitaria Sanitas

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Virtual Reality; Vaccination; Child, Preschool; Phlebotomy; Procedural Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural
• Other Study ID Numbers: VRPedPain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No