Recruitment, randomisation and follow up
After written informed consent, eligible women were randomly allocated
using sealed envelopes to either the virtual reality intervention or
standard care. Using a secure online system, a randomisation scheme
based on permuted block of random block sizes (2, 4) and stratified by
parity (nulliparous, multiparous) and menopausal status (premenopausal,
post- menopausal), created the allocation sequence. Due to the nature of
the intervention, blinding of participants, care providers and outcome
assessors was not possible, but allocation remained concealed until
randomisation.
The intervention group received the virtual reality device with
immersive video content for the use during their outpatient hysteroscopy
as a distraction method. In the standard care group, women underwent
their outpatient hysteroscopy as a routine procedure without offering
the virtual reality intervention. Patient follow up was clinically
indicated, not arranged for the purpose of the trial.