Effectiveness of immersive Virtual Reality on pain perception in children associated with vaccination: randomized pilot study
- Conditions
- VaccinationBehaviorPainM01.060.406
- Registration Number
- RBR-483ndsd
- Lead Sponsor
- niversidade Federal de Santa Catarina
- Brief Summary
Vaccination is an effective, available and reliable intervention that prevents infectious and debilitating diseases. However, it occurs more frequently in childhood, which can contribute to the development of trauma. Therefore, non-pharmacological interventions can be used to try to avoid this type of reaction, as virtual reality is one of them, as it allows the child to be immersed in a virtual, three-dimensional environment that provides distraction and reduces pain perception. Check feasibility of a pilot study of a randomized clinical trial on the effectiveness of immersive virtual reality glasses in terms of children's pain perception associated with intramuscular vaccination in relation to the traditional method. Pilot study of a randomized, controlled, parallel and open clinical trial, carried out in four vaccination units in Southern Brazil, between August and November 2023, with children between four and six years, 11 months and 29 days. The intervention group used immersive virtual reality glasses during the intramuscular vaccine, while the control group received the traditional clinical method, with both groups receiving the instructional therapeutic toy to prepare children during the vaccine. The association between the variables was verified using Pearson's chi-square test (X2) or Fisher's exact test with Confidence Intervals (CI) of 95%, and a significance level of 5% (p-value=0.05 ). Furthermore, the agreement between the pain reported by the child and the pain observed by the researcher and guardian was verified using Cohen's Kappa test. And, the criteria to test the feasibility of the protocol were: eligibility, recruitment, protocol fidelity; retention/friction; and, missing data, as well as the sample size was calculated. The study was approved by the Ethics Committee under opinion number 6,045,606. Of the 50 eligible participants, 48 ??were randomized and included in the final analysis, 23 children allocated to the intervention group and 25 to the control group. Furthermore, it was found that 17 (74%) children in the intervention group stated that they did not feel pain during the intramuscular vaccination using immersive virtual reality glasses, while only 6 (24%) children in the control group reported that they did not feel pain. However, there was no statistical difference when comparing the perception of severe pain reported by the children compared to the researcher's observation and the guardian's observation. Yelling and whining behavior were lower in the intervention group. In this pilot study there was a statistical difference between the groups in relation to pain reduction, since the control group had more severe pain, as well as the behaviors during the procedure were more intense.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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