136 Chapter 6 Outcomes The primary outcome of this study was pain experience during the HSG procedure, defined as the overall pain and the most severe pain experienced. Pain was measured using a VAS ruler (scale 0.0 - 10.0cm). Secondary outcomes included satisfaction, usage of oral analgesics following HSG, preference of type of VR distraction, and side effects. The anxiety level and the VR expectations prior to HSG were reported through a questionnaire, since these were considered possible confounding factors. Data collection First, all participants received a short questionnaire with an adapted version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS; N. Moerman, F.S.A.M. van Dam, M.J. Muller and J. Oosting) to determine their level of anxiety while waiting for the procedure. It additionally contained questions on their expectations and expected preferences of the VR headset and questions on their usage of oral analgesics prior to the procedure were asked. The questions on VR software preference included open field questions to explore the rationale for preferences. Immediately after the procedure, participants were asked to score their highest pain level and their overall pain level during HSG using a VAS-ruler (0.0 - 10.0cm). The second questionnaire was completed within 30 minutes after the HSG and contained questions on possible side effects of the use of VR and participant satisfaction with the procedure (5-point Likert scale). In addition, participants in the intervention group received questions on their satisfaction with their chosen VR application. Finally, the third and last questionnaire was sent to all participants by email using Castor EDC, a day after the procedure. This last questionnaire inquired on side effects or complaints, willingness to undergo the procedure again and use of oral analgesics in the first 24 hours after the procedure. All questionnaires can be found in the appendix S3. A subgroup of patients received a more elaborate questionnaire before and immediately after the procedure with questions on their expectations of VR and their experiences. Medical details from the HSG procedure (for example the type and volume of contrast medium used, instrument used for instalment of contrast) and results of the HSG were collected from the patient files. Statistics All data were analysed according to the intention-to-treat principle using IBM SPSS for Windows, version 26.0 (IBM Corp., Armonk, NY, USA). Baseline characteristics were presented using descriptive statistics with median and interquartile range for non-
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