ObjectiveTo test whether headset-delivered virtual reality (VR) content affects satisfaction and/or anxiety in women with cervical squamous intraepithelial lesions undergoing colposcopy and colposcopically guided cervical biopsy.MethodsIn this single-center, randomized trial, the authors measured overall satisfaction (100-mm visual analog scale) and situation-specific anxiety (STAI-S) in 247 women with suspected cervical squamous intraepithelial lesions wearing either no VR headset (arm 1, control) or a VR headset before (arm 2) or before and during colposcopy (arm 3). Secondary endpoints were pain, discomfort, and anxiety during colposcopy, heart rate, and 72-hour follow-up parameters: overall satisfaction, bleeding severity, bleeding duration, pain, and use of analgesics. Analysis was by intention to treat.ResultsMedian values for overall satisfaction were 100 (interquartile range, 90–100) in controls (n = 83), 100 (95–100) in arm 2 (n = 82), and 100 (95–100) in arm 3 (n = 82), respectively (p = .92). The median Δ of situational anxiety (baseline vs after colposcopy) was −8 (−13 to −3), −8 (−16.5 to −4), and −10 (−20.5 to −4.5), respectively (p = .09). The secondary endpoints pain during colposcopy (20 [10–50] vs 20 [10–40] vs 30 [10–50]; p = .65), discomfort during colposcopy (30 [10–50] vs 30 [10–50] vs 20 [10–50]; p = .46), and anxiety during colposcopy (20 [0–50] vs 10 [0–40] vs 10 [0–30]; p = .44), were not different between arms. Follow-up data showed no improvement in the 2 VR arms compared with controls (overall satisfaction, p = .37; bleeding severity, p = .09; pain level, p = .89; duration of pain; p = .23; and use of analgesics; p = .39). Per-protocol analysis did not change the results.ConclusionsA VR headset showing a 360-degree surround vision film has no effect on satisfaction or anxiety in women undergoing colposcopy.