Virtual Pain Care Trial

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Mar 15, 2023

Keywords

ClinConnect Summary

This study is testing whether using Virtual Reality Therapy (VR) during wound care can reduce pain and anxiety for adults. Participants are randomly assigned to either receive the VR system (glasses and headphones with the VRelax program) in addition to usual wound care, or to receive the usual wound care without VR. The VR is used about 10 minutes before the wound care and continues until about 1 minute after. The main goal is to measure how pain changes from before to after the first wound care visit using a simple 0–10 pain scale. They’ll also look at other things like average pain across visits, anxiety after the procedure, how satisfied patients and providers are, and several vital signs during and after treatment.

To be eligible, adults 18 or older who need wound care and are expected to have 1–3 painful, sequential wound care visits can enroll. They must have had at least one painful prior wound care with a pain score of 4 or higher (or report a pain level of 4+ before starting wound care). People who don’t understand Dutch well, have dementia or epilepsy, migraines, severe dizziness/nausea, claustrophobia, or other conditions that prevent using VR gear, or who can’t give informed consent, are not eligible. The trial is taking place at Amsterdam University Medical Center in the Netherlands, started in 2023, with about 32 participants planned. It is not blinded (participants and care providers will know who is using VR), and enrollment is by invitation. The study is expected to complete around November 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals aged 18 or older with wounds receiving wound care
• • Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures
• • At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.
• Exclusion Criteria:
• • Individuals not being able to understand Dutch language at primary school level
• • Individuals not being able to read or write Dutch
• • Individuals diagnosed with dementia and/or cognitive impairment
• • Individuals diagnosed with epilepsy
• • Individuals diagnosed with migraine
• • Individuals with severe dizziness and/or nausea
• • Individuals with a known history of claustrophobia
• • Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
• • Individuals who have no feeling in the wound care area
• • Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones