Non-immersive Virtual Reality for Pediatric Pain Management

Procedural Pain Clinical Trial

Official title:

Non-immersive Virtual Reality for Pediatric Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985930
• Other study ID #: VRPedPain
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2023
• Source: Sanitas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Procedural
• Procedural Pain

Intervention

Device:
• Distraction with virtual reality
Distraction content delivered through virtual reality goggles

Other:
• Treatment as Usual
Treatment as Usual

Locations

Country	Name	City	State
Colombia	Fundación Universitaria Sanitas	Bogotá	Bogotá D.C.

Sponsors (2)

Lead Sponsor	Collaborator
Claudia Aristizábal	Sanitas University

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	LLANTO Crying	Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2).	Immediately after procedure
Secondary	LLANTO Attitude	Subcomponent of the LLANTO scale scored as at ease or sleeping (0), restless (1), or agressive (2).	Immediately after procedure
Secondary	LLANTO Breathing	Subcomponent of the LLANTO scale scored normal (0), tachypneic (1), or irregular (2).	Immediately after procedure
Secondary	LLANTO Facial expression	Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2).	Immediately after procedure
Secondary	LLANTO Postural muscle tone	Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2).	Immediately after procedure
Secondary	Interrater reliability of the LLANTO scale	Between parents, nurse and physician	During the statistical analysis stage