137 VR for pain relief in HSG 6 normally distributed continuous variables, and with mean and SD for normally distributed continuous variables. Categorical variables were presented as absolute numbers and percentages. Continuous outcomes were analysed with the use of an independent t-test or the Mann-Whitney U-test as appropriate, whereas categorical variables were analysed with use of the Chi-square test or the Fishers exact test. Two-sided P values of less than 0.05 were considered to indicate statistical significance. A multiple linear regression model was fitted to assess the influence of predefined confounders on the primary outcome measures. Anxiety level, VR expectations and use of analgesics were analysed as possible confounders prior to the procedure. The used instruments during HSG, type of contrast used and HSG outcomes were analysed as possible confounders during the HSG procedure. Sample size Based on previous research in a similar, Dutch population, we anticipated an overall pain score of 5.0 cm (in VAS, scale 0.0 - 10.0 cm) in the control group (5). To detect a difference of 1.5cm in pain score, we calculated that the trial needed a sample size of 134 women (67 in each group) to obtain a power of 80%, with an alpha of 5% and a loss to follow-up rate of 5% using PASS (15.0.5). RESULTS Between January 2021 and October 2022, 211 women were screened for eligibility, of which 185 were eligible and 135 provided informed consent. We randomly allocated 70 women to HSG with VR (intervention group), and 65 to HSG without VR (control group). One woman from the intervention group did not undergo HSG after randomization and was considered a drop-out (Figure 2). Randomization led to two equal groups in terms of baseline characteristics. The baseline characteristics are shown in Table 1.
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