The Use of Virtual Reality During Extraamniotic Balloon Insertion for Pain and Anxiety Relief: A Randomized Controlled Trial [ID: 1376399]

INTRODUCTION: Induction of labor (IOL) with extraamniotic balloon (EAB) catheter is a procedure commonly associated with maternal discomfort, pain, and anxiety. We aimed to investigate the distractive effect of virtual reality (VR) technology on pain and anxiety in pregnant women who undergo IOL with EAB. METHODS: In this randomized controlled trial, pregnant women intended for IOL with EAB at term, were recruited, signed a consent form, and randomized into two groups. The control group received the institutional standard care for EAB insertion, while women in the VR group were exposed to a VR clip during the procedure. Pain scores (expressed by Visual Analog Scale [VAS]) were obtained before, during, and after EAB insertion. Anxiety levels (expressed by validated State-Trait-Anxiety Inventory Scale [STAI-S]) were obtained before and after the procedure. Maternal satisfaction was also recorded. The primary outcome was the VAS score during EAB insertion. RESULTS: Total of 145 women were recruited 1:1 ratio. There were no differences between groups in terms of age, body mass index, gestational age at enrollment, indication for IOL, or preprocedural VAS score and anxiety levels. VAS score during the procedure was significantly lower in the VR group compared to the control group (4.62±2.89 versus 5.95±3.18, P =.04). In addition, the VR group benefited from a higher rate of anxiety relief expressed by the difference between preprocedure and postprocedure STAI score (7.09±10.45 versus 2.84±8.65, P =.039). Women in the VR group reported an overall very high (93%) satisfaction score. CONCLUSION: In this randomized controlled trial, we demonstrated that the use of VR technology in women undergoing IOL with EAB was associated with lower VAS scores during the procedure, with significant anxiety reduction, and a higher satisfaction score, compared to women who received standard care.