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. 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. 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 mmHgvs. 121.8/64.7 mmHg). There were no VR-related adverse effects, and patient satisfaction was high for both groups. 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.
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