Vaccination
Conditions
Interventions
This is a randomized, controlled, parallel and open clinical trial, which was carried out simple randomization, through the website www.random.org. by another researcher not linked to this project. Ex
L01.224.160.875
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
4 Years to 6 Years
Inclusion criteria
Inclusion criteria: Children between four and six years, 11 months and 29 days; any ethnicity; both sexes; accompanied by parents or legal guardian; received at least one of the five vaccines recommended for the age group; presented cognitive and emotional conditions that enabled the application of the data collection instrument
Exclusion criteria
Exclusion criteria: Child with visual impairment or significant reduction in visual acuity; epilepsy/seizure; pre-existing migraines; changes in sensitivity (decrease or increase) that generated discomfort during the use of virtual reality glasses (labyrinthitis); children with psychiatric illnesses; mood changes diagnosed in an acute state (anxiety and phobias); children with infections; burns or injuries to the face or head that interfered with putting on the immersive virtual reality glasses; strabismus; change in bone shape that made it difficult to adapt virtual reality glasses; having undergone an invasive procedure on the same day as vaccination, withdrawal of participation by the child or parents/legal guardian; presence of nausea; vomiting or other discomfort during the intervention with the immersive virtual reality glasses that did not allow the continued use of the virtual reality glasses; children who used oral, intramuscular or topical (at the site of the intramuscular procedure) analgesics (in less than 12 hours); wished not to use the immersive virtual reality glasses during the intramuscular vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Decrease in pain reported by the child, verified using the FPS-R Scale;Outcome found 1: There was a reduction in pain in 74% of children in the intervention group, while in the control group only 24% reported not feeling pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: Perception of pain reduction observed by the researcher and guardian, verified using the FPS-R Scale;Outcome found 2: The pain was reported by the researcher to be stronger in the control group (52%) compared to the intervention group (8.7%), congruent with the observation of the guardian, who reported the strongest pain in the control group (60% ) when compared to the intervention group (8.7%);Expected outcome 3: Child behavior, indicated using ten variables from the OSDB Scale;Finding 3: Yelling and whining behaviors were lower in the intervention group when compared to the control group | — |
Countries
Brazil
Contacts
Public ContactMichel Vitor
Universidade Federal de Santa Catarina
Outcome results
None listed