Efficacy of virtual reality therapy versus pharmacological sedation for reducing pain and anxiety during coronary catheterisation procedures: A prospective randomised controlled trial

Abstract Background and Aims The use of virtual reality (VR) therapy has grown considerably, as it is effective for reducing pain and anxiety in different clinical areas. However, it has not been well evaluated for coronary angiography and angioplasty. This study aimed to compare VR therapy with pharmacological sedation (Sedation) for reducing pain in patients undergoing a planned coronary angiography or coronary/peripheral angioplasty. Methods In this prospective randomized controlled trial, patients were randomly allocated to one of two groups before catheterization: a Sedation group (injection of midazolam and fentanyl) or a VR group (Deepsen VR headset). The primary outcome measure was the maximum pain during the procedure (visual analogue scale: 0–10). The secondary outcome measures were anxiety following the procedure (Spielberger State Anxiety Inventory: 20–80), the occurrence of arterial spasm, the haemodynamic profile and patient satisfaction. Results The VR group ( n = 63) had a mean pain rating of 2.5; for the Sedation group ( n = 59) this was 1.0. This did not meet the criterion for non‐inferiority. Anxiety was comparable between the two groups (VR: 25.4; Sedation: 24.7), as was the occurrence of arterial spasm (VR: 7.9%; Sedation: 8.5%; p = 0.91), but blood pressure was higher in the VR group (140.2/71.7 mmHg vs. 121.8/64.7 mmHg). There were no VR‐related adverse effects, and patient satisfaction was high for both groups. Conclusions Virtual reality therapy was not non‐inferior to pharmacological sedation for reducing pain during coronary angiography or angioplasty. However, it reduced anxiety to a comparable level. Virtual reality therapy represents an alternative to pharmacological sedation, which is well accepted by patients.