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.