Outcomes and measurements
Primary outcome measurements were worst and average pain, based on numeric rating scores (11-point scale from 0 to 10; 0 representing ‘no pain/anxiety’ and 10 representing ‘worst imaginable pain/anxiety’) along with anxiety, recorded pre-procedurally (as ‘anticipated’ prior to the procedure) and that ‘experienced’ during the procedure28, 29,30. Data was collected immediately before and after the procedure. Data on the proportion of patients eligible, stratification factors (menopausal status and parity) consented and randomised, reasons for non-participation, and acceptability of the trial and intervention to participants and healthcare providers, were collected. The perception of the clinician performing the procedure and the nursing staff regarding feasibility of using the virtual reality equipment for each patient who had the intervention was assessed through questionnaires. Semi-structured interviews were conducted with women who received the virtual reality intervention within 30 minutes of the procedure and were recorded on a digital voice recorder. The questions focused on the patient’s experience of the hysteroscopy and the intervention, pain and anxiety perceived and also any other aspects that they felt were relevant to hospital care. The interviews allowed for all participants to be asked similar questions within a flexible framework.31
Interviews continued until no new information was being obtained and theoretical saturation point was reached.32