Background: Visual and acoustic virtual reality (VR) has been increasingly explored as a non-pharmacological tool for pain relief in clinical settings.Objective: We aimed to evaluate the effectiveness of VR as a distraction technique in the management of acute pain during operative hysteroscopy in the outpatient setting.
Methods:A prospective, open-label, randomized control trial in a tertiary university-affiliated medical centre between April and August 2020. Overall, 82 women were randomly allocated to undergo operative hysteroscopy either with the use of VR (n = 44, study group) or with standard treatment (control group, n = 38). VR was applied throughout the procedure and no anaesthesia was given. The primary outcome measures included self-reported intraoperative pain. Other objectives included vital parameters as pulse rate (PR) and respiratory rate (RR) before and during the first 3 min of the procedure. Pain and anxiety outcomes were measured as numeric rating scores.
Results:The baseline parameters were similar between groups. The mean duration for the procedure was 8.1 ± 3.2 vs. 7.3 ± 6.0 min for the study and the control groups (p = 0.23). There were no statistically significant differences between the reported pain scores during the procedure [median (interquartile range) 5.0 (3.0-7.2) vs. 5.0 (3.0-8.0), respectively; p = 0.67]. While neither intraoperative heart rate nor respiratory rate differed between groups [14.0 (13.0-16.0) vs. 14.0 (11.0-16.5); p = 0.77)], the increase of heart rate was found greater in the VR group [+7.0 (8.5) vs. +1.0 (12.2); p = 0.01].
Conclusion:VR was not effective in reducing pain during an outpatient operative hysteroscopy.Significance: The use of a Virtual reality system was found ineffective in reducing pain during and after an office operative hysteroscopy without anaesthesia, in a thorough examination of both continuous physiological parameters and women's self-reported measures.This accompanies the following article: Dualé, C & Mourgues, C. The price of pain relief, or should non-invasive medical devices be treated differently in analgesic clinical trials?.