RESUMO
BACKGROUND: Induction of labor with an extra-amniotic balloon catheter is a procedure commonly associated with maternal discomfort, pain, and anxiety. OBJECTIVE: We aimed to investigate the distractive effect of virtual reality technology on pain and anxiety among pregnant patients who underwent induction of labor with an extra-amniotic balloon catheter. STUDY DESIGN: In this randomized controlled trial, pregnant patients who were undergoing planned induction of labor using an extra-amniotic balloon catheter at term for various obstetrical indications were recruited and randomized in a 1:1 ratio into 2 groups. Patients in the virtual reality group were exposed to a virtual reality technology clip (using SootheVR All-In-One virtual reality care system for pain and anxiety) during the entire extra-amniotic balloon catheter insertion, whereas patients in the control group received the institutional standard care for extra-amniotic balloon catheter insertion. Pain scores, expressed as visual analog scale scores, and maternal hemodynamic parameters were obtained before, during, and after extra-amniotic balloon catheter insertion. Anxiety was evaluated using the validated State-Trait Anxiety Inventory Scale before and after the procedure. Maternal satisfaction with the virtual reality technology was also recorded. The primary outcome was the change in visual analog scale score before and during extra-amniotic balloon catheter insertion. Among the secondary outcomes was the change in anxiety levels before and after extra-amniotic balloon catheter insertion. The study was powered to detect a 25% decrease in the primary outcome. RESULTS: A total of 132 pregnant patients were recruited (66 in each group). There were no differences between groups in terms of age, body mass index, gestational age at enrollment, indication for induction of labor, and preprocedural visual analog scale score and anxiety levels. The change in visual analog scale score (maximal visual analog scale score during the procedure minus the initial visual analog scale score before the procedure, ie, the primary outcome) was significantly lower in the virtual reality group than in the control group (2.78±3.0 vs 4.09±2.99; P=.01). In addition, the virtual reality group experienced a higher rate of anxiety relief, expressed as the difference between the preprocedure and postprocedure State-Trait Anxiety Inventory Scale scores (-6.46±9.6 vs -2.01±9.11; P=.007). Patients in the virtual reality group reported a very high overall (94%) satisfaction score. CONCLUSION: In this randomized controlled trial, we demonstrated that the use of virtual reality technology among patients who underwent induction of labor using an extra-amniotic balloon catheter was associated with lower visual analog scale scores during the procedure and a significant reduction in anxiety than patients who received standard care. There was also a very high satisfaction rate with the use of virtual reality technology.