Non-immersive Virtual Reality for Pediatric Pain Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-12-01

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.

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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.

Conditions

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Procedural Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Distraction Group

Children between the ages of 3 and 5 years will be distracted using virtual reality content delivered through goggles.

Group Type EXPERIMENTAL

Distraction with virtual reality

Intervention Type DEVICE

Distraction content delivered through virtual reality goggles

Treatment as Usual

Children randomized to this group will receive the usual medical care.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type OTHER

Treatment as Usual

Interventions

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Distraction with virtual reality

Distraction content delivered through virtual reality goggles

Intervention Type DEVICE

Treatment as Usual

Intervention Type OTHER

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes