130 Chapter 6 ABSTRACT Study question Is Virtual Reality an effective non-pharmacological tool to reduce procedural pain during hysterosalpingography (HSG)? Summary answer An HSG with Virtual Reality does not result in lower pain scores than an HSG without Virtual Reality. What is known already An HSG is often rated as uncomfortable or painful, with a median pain score of 5, measured using the Visual Analogue Scale (VAS, scale 0.0-10.0cm). Virtual Reality has been proven successful to reduce acute procedural pain during different medical procedures and interventions. Study design, size, duration We performed a two-centre open label randomized controlled trial between January 2021 and October 2022. After informed consent, women were randomized between HSG with or without Virtual Reality headset during HSG. Due to the nature of the intervention, the study was not blinded. The study was registered in the Netherlands Trial register with registration number NL9203. Participants/materials, setting, methods The primary endpoint was procedural pain, measured using VAS (scale 0.0 – 10.0cm). Procedural pain consisted of overall pain score and peak pain score during the procedure measured immediately after the HSG procedure. Secondary endpoints included use of analgesics after the procedure, satisfaction, Virtual Reality preferences and side effects. Main results and the role of chance We randomized a total of 134 women, 69 to the intervention group and 65 to the control group. The mean VAS for peak pain was 6.8 in the intervention group versus 6.6 in the control group (p-value 0.574). The mean VAS for overall pain was 5.0 in the intervention group versus 4.9 in the control group (p-value 0.915). The use of analgesics within the first 24 hours after the HSG was comparable between the two groups (18.8% in the intervention group versus 21.3% in the control group). Satisfaction scores were also comparable. There were no differences in the prevalence of symptoms that are associated as side effects of the use of Virtual Reality. The mean score for being distracted by Virtual Reality was 3.54 on a scale of 1-5.
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