No anxiety or pain reduction by Virtual Reality during oocyte retrieval in IVF/ICSI treatment: results of a randomized controlled trial.

study questionWhat is the effect of Virtual Reality (VR) on anxiety and pain during oocyte retrieval in IVF/ICSI treatment? SUMMARY ANSWER: There is no significant effect of VR on anxiety and pain during oocyte retrieval in IVF/ICSI treatment. WHAT IS KNOWN ALREADY: Patients undergoing oocyte retrieval in IVF/ICSI treatment often experience anxiety and pain, despite conscious sedation. VR might offer a solution since it has been successful in reducing procedural anxiety and pain during medical procedures, with the potential to replace standard analgesic care. STUDY DESIGN, SIZE, DURATION: A single-centre, open-label, randomized controlled trial was conducted between February 2023 and August 2024. Due to the nature of the intervention, the study was not blinded. PARTICIPANTS/MATERIALS, SETTING,

methodsPatients undergoing oocyte retrieval as part of IVF/ICSI treatment were screened. After providing informed consent, participants were randomized between oocyte retrieval with VR added to conscious sedation and oocyte retrieval with conscious sedation only. When assigned to the intervention group, patients received the VR intervention through a head-mounted device, showing nature films and relaxation exercises. This was added to standard care which includes analgesia and sedatives. Sounds were delivered through the head-mounted device or headphones. The primary outcome was pre- and post-procedural anxiety, measured using the STAI questionnaire. Secondary outcomes included procedural pain (NRS, scale 0-10), satisfaction scores (NRS, scale 0-10), VR preferences, and side effects. MAIN RESULTS AND THE ROLE OF CHANCE: There were 113 participants included: 57 in the intervention group receiving VR and 56 in the control group not receiving VR. We observed no differences between the intervention and control groups in pre-procedural anxiety (mean difference (MD) 0.14 (95% CI -1.78, 2.05), P = 0.885), post-procedural anxiety (MD 0.45 (95% CI -1.21, 2.11), P = 0.589), overall pain (MD -0.12 (95% CI -0.97, 0.73), P = 0.779), and peak pain (MD 0.59 (-0.51, 1.68), P = 0.287). LIMITATIONS, REASONS FOR CAUTION: VR might only be effective for a certain group of patients undergoing retrieval, or might be more effective in reducing pre-procedural anxiety, which in turn might lead to a reduction in procedural pain. Furthermore, it might reduce pain up to a certain threshold, or be effective when the duration of the procedure is short. WIDER IMPLICATIONS OF THE

findingsSince VR does not affect anxiety and pain for the general patient population undergoing oocyte retrieval, we do not advise incorporating VR to standard IVF/ICSI anxiety and pain management. For future studies, it is important to investigate which subgroup could benefit from VR and how it could be implemented to study interventions from a non-pharmacological approach. Patient preferences regarding anxiety and pain management during IVF/ICSI treatment should be considered. STUDY FUNDING/COMPETING INTEREST(S): External funding from ZonMw (Grant number 838002978), the Implementation and Scale-up Coaching, and the Eggcelent Change grant from Theramex have been received for this study to cover the costs of the VR devices. A.P.v.H. and K.R. report to have received a travel grant from Merck to visit ESHRE 2022. A.M.F.S. reports to have been an invited speaker at ESHRE where travel and hotel costs are covered. V.M. reports to have received institutional research grants from Guerbet, Merck, and Ferring. He has received travel and speaker's fees from Guerbet. J.W.K. reports to be on the Advisory board of Boston Scientific, Saluda, Nevro, Abbott, and Medtronic, and received consulting fees from these organizations. He is a board member of the BNS. KD reports to have received an institutional research grant from Guerbet, a speaker's fee from Guerbet, and financial support to attend meetings by Merck and Guerbet. TRIAL REGISTRATION NUMBER: NCT05555498. TRIAL REGISTRATION DATE: 26 September 2022. DATE OF FIRST PATIENT’S ENROLMENT: 7 February 2023.