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Study of a virtual reality intervention for pain and anxiety control in pediatric vaccination

VR4PV: superiority randomised controlled trial of a virtual reality intervention versus treatment as usual for pain and anxiety control in pediatric vaccination

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55932023
Enrollment
269
Registered
2023-12-19
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and anxiety associated with vaccination procedures Not Applicable

Interventions

Participants are five-year-old children, registered at two Personalized Health Care Units (UCSP) and one Family Health Unit (USF) in the center of Portugal. Children eligible for vaccination will be i
parents and children will be informed of the camera´s presence and its purpose before the vaccination. Then children respond to the Children's Fear Scale (CFS) to assess anxiety before Immunization im
children will answer the Children's Fear Scale (CFS) and the Faces Pain Scale–Revised (FPS-R) to assess pain after the two vaccines. The proced

Sponsors

Nursing Research, Innovation and Development Centre of Lisbon (CIDNUR)/ Lisbon School of Nursing
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactLeonor Roque
geral.ucspcbranco@ulscb.min-saude.pt+351 272 340 150

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026