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