Abstract
External cephalic version (ECV) is associated with a moderate degree of pain. Virtual reality (VR) is a technology that has shown promise in offering procedural analgesia. We undertook a clinical pilot to assess the viability of VR to reduce pain during ECV. In an open randomised controlled trial (RCT), we randomised 50 women to either VR or standard care each (25 per group). Women receiving VR were administered VR content (Skylights) via a headset. Pre- and post-procedural measures of pain, anxiety, device experience and vital signs were measured. There were no significant differences between groups (VR/no VR) in pain scores (60.68 vs 49.76; p = 0.2), ECV success rates (80% vs 76%; p = 0.7) or anxiety levels. The women receiving VR had a significantly higher anticipation of pain pre-procedurally (70.0 vs 50.0; p = 0.03). 20 (80%) of the VR women indicated that they would use VR again and 22 (88%) indicated they would recommend it to a friend having ECV. There were no significant differences between groups for side effects encountered or changes in vital signs. We have shown that using VR during ECV is feasible and appears safe. Our results inform the design of future RCTs.
Highlights
The primary outcomes of interest for the study involved assessing between group differences in pain scores, anxiety scores, physiological parameters [heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP)], women’s acceptance/feedback of the procedure, and side effects encountered between the intervention (VR) and control
Patient characteristics. 54 women were enrolled into the study. 50 women completed it (Fig. 1). 25 women were randomised to the intervention group and 25 women were randomised to the control group
There were no significant differences between both groups in relation to their pre-procedural anxiety levels, physiological parameters or attitudes towards the External cephalic version (ECV) procedure
Summary
Given the potential of VR to facilitate non-pharmacological analgesia, the question of its utility in reducing procedural pain during ECV merits consideration. This prompted us to design a pilot study to evaluate the use of VR as an analgesic during ECV. The objective of this pilot was to assess feasibility of concept and lay the foundations for an adequately powered randomised controlled trial (RCT) to test the performance of VR against the standard of care for all women undergoing ECV. The primary outcomes of interest for the study involved assessing between group differences in pain scores, anxiety scores, physiological parameters [heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP)], women’s acceptance/feedback of the procedure, and side effects encountered between the intervention (VR) and control (no VR).
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