A Randomized Study on Use of Virtual Reality Technology for Pain Relief in Transvaginal Oocyte Retrieval Under Conscious Sedation

Title: A randomized study on use of virtual reality technology for pain relief in transvaginal oocyte retrieval under conscious sedation Objectives: The study is to evaluate the effectiveness of virtual reality (VR) in pain relief during transvaginal ultrasound-guided oocyte retrieval (TUGOR) under conscious sedation Hypothesis to be tested: VR can reduce the pain level during TUGOR. Design and subjects: This is a randomized study on additional use of VR during TUGOR. A total of 160 women undergoing oocyte retrieval on both ovaries will be recruited and randomized to one of the following groups: active and placebo groups. Those with known allergy to pethidine, diazepam or local anaesthetics; and history of claustrophobia/ susceptible to motion sickness will be excluded.

Instruments: Immersive VR Interventions: All received women will receive the standard conscious sedation with 25mg IV pethidine and 5mg IV diazepam; and paracervical block of 10ml 1% lignocaine. VR headset will be put on for every woman. It will only be switched on for the active VR group but not the placebo VR group.

Main outcome measures: The primary outcome measure is the maximal abdominal pain levels during TUGOR measured by a 100mm linear visual analogue scale prior. Secondary outcome measures include the pain of vaginal puncture and the abdominal pain four hours after the procedure prior to discharge from hospital.

Data analysis and expected results: Data will be analysed on intention to treat basis and per protocol. Demographic features of the study groups will be compared. Chi-square test or Fisher's exact test will be used for categorical variables. Mann-Whitney U test will be used to compare the continuous variables between groups. P values of <0.05 will be considered statistically significant.