A virtual reality system for pain and anxiety management during outpatient hysteroscopy—A randomized control trial

Abstract

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?.

The effect of informing the patient about the procedure with video imaging before office hysteroscopy on pain

“…In their study with 82 patients, Fouks et al found that visual and acoustic virtual reality before OH did not reduce post‐procedure pain and did not positively affect physiological parameters (heart rate and blood pressure) 25 . They found no difference between the groups in terms of pre‐ and post‐procedure systolic and diastolic blood pressures.…”

“…24 In their study with 82 patients, Fouks et al found that visual and acoustic virtual reality before OH did not reduce post-procedure pain and did not positively affect physiological parameters (heart rate and blood pressure). 25 They found no difference between the groups in terms of pre-and post-procedure systolic and diastolic blood pressures. Although the increase of heart rate was found greater in the virtual reality group, there was no statistically significant difference between the control group and the virtual reality group in terms of heart rate before and after the procedure.…”

Does virtual reality technology reduce pain and anxiety during outpatient hysteroscopy? A randomised controlled trial

“…A second trial involving 82 participants 21 also found that the use of VRT did not significantly reduce pain. Additionally, in that study, pulse rate and respiratory rate were measured during the procedure to obtain more objective measures of pain and anxiety.…”

“…This provides the user with a realistic immersive virtual environment which can be interacted with. 14 VRT has been utilised in the medical field to aid surgical training, patient education, rehabilitation as well as pain and anxiety management for a variety of diverse scenarios including burns management, medical procedures, dentistry and labour [14][15][16][17][18] However, currently there are only three published trials [19][20][21] investigating the use of VRT during OPH and these offer conflicting results on its effectiveness, meaning clarification is needed.…”

The price of pain relief, or should non‐invasive medical devices be treated differently in analgesic clinical trials?

“…This journal recently published a paper entitled 'A virtual reality system for pain and anxiety management during outpatient hysteroscopy-A randomized-control trial' (Fouks et al, 2021). In this study involving 82 patients, the authors failed to evidence any superiority of immersive virtual reality (VR) versus care-as-usual (CAU), whereas other published studies, such as several ones in paediatrics (Eijlers et al, 2019;Lambert et al, 2020), were in favour of VR.…”