The use of virtual reality during extra-amniotic balloon insertion for pain and anxiety relief—a randomized controlled trial

Abstract

Background: Induction of labor with extra-amniotic balloon (EAB) catheter is a procedure commonly associated with maternal discomfort, pain, and anxiety. Objective(s): We aimed to investigate the distractive effect of virtual reality (VR) technology on pain and anxiety- in pregnant patients who undergo Induction of labor with EAB.Study design: In this randomized controlled trial, pregnant patients intended for Induction of labor with EAB at term, for various obstetric indications, were recruited and randomized in a 1:1 ratio into two groups. Patients in the VR group were exposed to a VR technology clip (using SootheVR All-In-One VR care system for pain and anxiety) during the entire EAB insertion while patients in the control group received the institutional standard care for EAB insertion. Pain scores expressed by Visual Analog Scale (VAS) and maternal hemodynamic parameters, were obtained before, during, and after EAB insertion. Anxiety was evaluated by the validated State-Trait Anxiety Inventory Scale (STAI-S) before and after the procedure. Maternal satisfaction from the VR technology was also recorded. The primary outcome was the change in VAS score before and during EAB insertion. Among the secondary outcomes was the change in Anxiety levels before and after EAB 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, BMI, gestational age at enrollment, indication for Induction of labor, and pre-procedural VAS score and anxiety levels. The change in VAS score (maximal VAS score during the procedure subtract the initial VAS score before the procedure, i.e the primary outcome) was significantly lower in the VR group compared to the control group (2.78±3.0 vs 4.09±2.99, p=0.01). In addition, the VR group benefited a higher rate of anxiety relief expressed by the difference between pre-procedure and post-procedure STAI score, (-6.46 ± 9.6 vs -2.01 ± 9.11, P=0.007). Patients in the VR group reported an overall very high (94%) satisfaction score.Conclusions: In this randomized controlled trial, we demonstrated that the use of VR technology in patients undergoing Induction of labor with EAB was associated with lower VAS scores during the procedure and significant anxiety reduction compared to patients who received standard care. There was also a very high satisfaction rate from the use of VR technology.