Pain and anxiety associated with vaccination procedures Not Applicable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children without distinction of sex or ethnicity, accompanied by legal guardians, who agreed to participate in the study and suitable for vaccination according to the chronology of the 2020 National Vaccination Program, with a reasonable understanding of Portuguese
Exclusion criteria
Exclusion criteria: Children with epilepsy, migraine or other neurological diseases, reports of episodes of discomfort associated with the use of earphones and/or the use of VR glasses in a playful context and auditory, visual and cognitive deficits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain is self-assessed by the child, using Faces Pain Scale-Revised (FPS-R) at 2 min post-vaccination. 2. Anxiety is self-assessed by the child, using children´s Fears Scale (CFS) at 2 min post-vaccination. 3. Face, legs, Activity, Cry, Consolability (FLACC) will be used to code the children´s behaviour, recorded on video (by researchers) after the vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-assessed anxiety pre-vaccination measured with FPS-R at 2 min before vaccination. 2. Demographics: Child's ethnicity, child´s sex, accompanying the child to the vaccine, children's previous experience with procedures measured by interview before the vaccination | — |
Countries
Portugal