Does Virtual Reality Technology Reduce Pain and Anxiety During Outpatient Hysteroscopy? A Randomised Controlled Trial

BACKGROUND Hysteroscopy is a common gynaecological procedure where a camera attached to a thin scope is passed into the uterus via the vagina and cervix in order to obtain views of the inside of the uterus. Hysteroscopy is used for the diagnosis and management of a variety of benign and conditions as well as the diagnosis of uterine cancer. It can be performed under general anaesthetic or in an outpatient setting without formal anaesthetic. The latter has several advantages when compared to hysteroscopy with general anaesthesia as it avoids the additional risk of general anaesthesia, has a quicker recovery time, shorter hospital stay and reduced cost. Outpatient hysteroscopy (OPH) is generally well tolerated although some women will experience significant pain and pain is one of the most common reasons for failure to complete the procedure. As pain is one of the leading reasons for procedure failure, finding ways to reduce pain and anxiety is of critical importance. The optimal method of controlling pain and anxiety during outpatient hysteroscopy is poorly understood and hotly debated. Conventional therapy, as recommended by the Royal College of Obstetricians and Gynaecologists, involves the use of simple pain killers taken prior to the procedure and sometimes local anaesthetic during the procedure if dilatation of the cervix is required (RCOG 2011).Virtual reality (VR) technology is a relatively new and promising technology which if used as a distraction technique, may be able to reduce pain and anxiety experienced from a wide range of medical procedures. Virtual reality (VR) is a human-computer interface that provides users with various physical sensations (e.g., visual, haptic, auditory) to increase realism in the virtual world (Seth et al. 2011). To date VR has been used in a wide variety of inpatient and outpatient clinical scenarios to reduce pain and anxiety including simple blood tests, ENT procedures and minor gynaecological procedures such as hysterosalpingograms (Chan et al 2018, Wang et al 2020 and Ahmadpoura et al 2019). However, currently, to the best of our knowledge, there is only one relatively small-scale trial investigating the use of VR in an outpatient hysteroscopy setting (Deo et al 2020) meaning further studies are urgently needed to clarify the situation.

RATIONALE FOR CURRENT STUDY The purpose of this study would be to determine if the use of VR technology can reduce pain and anxiety experienced by patients during outpatient hysteroscopy procedures when compared to standard pain management.

The optimal method of controlling pain and anxiety during outpatient hysteroscopy is poorly understood and there is a wide variation in clinical practice. This study aims to test whether VR technology could reduce pain and anxiety as a relatively simple and safe adjunct to conventional pain management. Although VR has been used in a variety of clinical settings to date, there is only one previous study investigating the use of VR in an outpatient hysteroscopy setting (Deo et al 2020). The rationale of this study would be to build upon this evidence by performing the first large scale adequately powered randomised control trial of the use of VR technology in this setting.The study team hypothesises that the use of VR technology will significantly improve pain and anxiety when compared to conventional pain management. Finding additional low risk ways of improving pain and anxiety during OPH is of critical importance in order to improve patient experience and the success rate of the procedure as pain is a major reason for unsuccessful OPH procedures.

2. STUDY OBJECTIVES

The primary objectives of this study are to determine if: