Receiving inpatient or outpatient medical care at the hospital for any somatic conditionan having an indication for virtual reality intervention as part of care as usual (distraction) to reduce pain or anxiety medical procedure in the hospital, for which distraction (using virtual reality) mey be helpful as a tool to reduce pain and anxiety
Conditions
Interventions
The use of VR in the pediatric population is increasing, and is already implemented in pediatric hospitals in the Netherlands. The VR-headsets / HMDs are used already in the Sophia Children’s Hospital
Distraction Plus software, developed by Sync VR Medical, a company focusing on the use of VR in medical settings.The MR type of HMD will be a PICO 4 Enterprise, which has a declaration of conformity.
Sponsors
Sync VR Medical, Vening Meinesz building C, Princetonlaan 6, 3584 CB Utrecht
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:Pediatric patients (6-18 years old)Receiving inpatient or outpatient medical care at the hospital for any somatic conditionIndication for VR (virtual reality) intervention as part of care as usual to reduce pain or anxietyInformed consent from patient and/or parents or legal representatives (depending on the age)For the healthcare professional:Informed consent from the healthcare professional either guiding the MR experience and/ or performing the medical / diagnostic procedure
Exclusion criteria
Exclusion criteria: Developmental delayHistory of epilepsy Severe visual impairmentReceiving anxiolytic or sedative medicationAdmitted to the Intensive Care UnitHead woundsNot able to understand or speak DutchDeemed not fit to participate due to any reason (high anxiety or too much pain, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the USEQ for pediatric participants. This is a questionnaire on the user experience for the use of VR devices. The English version has been validated for this indication. Currently, we are validating the USEQ for Dutch language and for pediatric patients in another study in Erasmus MC Sophia (MEC-2025-0227). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints Secondary endpoint is the user experience of healthcare professionals providing the MR experience and / or performing the medical procedure, and their opinion of the feasibility of MR in de pediatric healthcare setting. Other study parameters Demographic data of the patients will be collected: age and gender, and type of medical procedure. Also, the healthcare professional type (doctor, nurse, etc) will be recorded. | — |
Countries
Netherlands
Contacts
Public ContactL.M. Staals
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed