Patient recruitment and characteristics
A total of 53 women were approached for 6 weeks between August 2018 and October 2018. Of these, 8 declined to participate and 5 did not meet eligibility criteria. Finally, forty of 48 (83%) women agreed to participate and were randomised. (Figure 1). Reasons for exclusion of the 5 patients included 4 patients being over the age of 70, of which one patient had hearing difficulty and 1 patient did not need a hysteroscopy. Eight patients declined to participate of which 2 patients wanted to see the procedure, 2 patients had used virtual reality before for gaming and were queasy, 2 patients were very anxious about the procedure and declined participation, 1 patient couldn’t wait for the procedure as there were delays in the clinic and 1 patient had brought her own headphones with an audio track to keep herself distracted. All patients completed the procedure except one having standard care who did not tolerate the procedure and needed to be booked for an outpatient hysteroscopy under general anaesthetic. Data for all 40 patients was considered for statistical analysis.
Baseline characteristics (Table 1) show that groups were balanced for features including age, parity, menopausal status, previous experience of outpatient hysteroscopy, anticipated pain and anxiety scores, and analgesic intake prior to the procedure. Before the procedure, the mean expected pain and anxiety scores were 6.7 and 5.98 respectively and there were no significant differences in either score between standard care and virtual reality groups. The procedures were performed in a single centre by 4 clinicians of consultant grade and a nurse and a healthcare assistant supported the clinics. Vaginoscopic approach was possible in 90% (36/40) of all the procedures. The mean duration of the procedure was 4.82 minutes (Range 1.5 minutes to 14 minutes). Local anaesthetic infiltration was required for pain management in 15% (6/40) of the 18% (7/40) of women had cervical stenosis. Eighteen percentage of the patients (7/40) had an experience of an outpatient hysteroscopy in the past.
Nausea was experienced by one patient in the virtual reality intervention arm, however she kept the headset on until the end of the procedure; one patient had previous history of claustrophobia and decided to removed the headset when the procedure started as she felt claustrophobic.