Clinical trial NCT03985930: Non-immersive Virtual Reality for Pediatric Pain Management
Official title: Non-immersive Virtual Reality for Pediatric Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Keywords: Child, Preschool
Virtual Reality
Procedural Pain
Phlebotomy
Vaccination
Lead sponsor: Sanitas University
Sponsor class: OTHER
Collaborators: name: Sanitas University
First posted: 2019-06-14
Enrollment: 122
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: LLANTO Pain level: LLANTO pain scale
timeFrame: Immediately after procedure
Secondary outcomes:
measure: LLANTO Crying
timeFrame: Immediately after procedure
measure: LLANTO Attitude
timeFrame: Immediately after procedure
measure: LLANTO Breathing
timeFrame: Immediately after procedure
measure: LLANTO Facial expression
timeFrame: Immediately after procedure
measure: LLANTO Postural muscle tone
timeFrame: Immediately after procedure
measure: Interrater reliability of the LLANTO scale
timeFrame: During the statistical analysis stage
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Universitaria Sanitas
state: Bogotá D.C.
Study officials:
affiliation: Fundación Universitaria Sanitas
name: Jhon H Camacho Cruz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: