STUDY QUESTION Is virtual reality (VR) an effective non-pharmacological tool to reduce procedural pain during hysterosalpingography (HSG)? SUMMARY ANSWER An HSG with VR does not reduce procedural pain scores compared to an HSG without VR. WHAT IS KNOWN ALREADY An HSG is often experienced as painful and uncomfortable. VR has been proven successful to reduce acute procedural pain during a variety of medical procedures and interventions. STUDY DESIGN, SIZE, DURATION We performed a two-centre open-label randomized controlled trial between January 2021 and October 2022. PARTICIPANTS/MATERIALS, SETTING, METHODS Women scheduled for HSG as part of their infertility work-up were screened for participation. After informed consent, women were randomized between HSG with or without VR. Due to the nature of the intervention, the study was not blinded. VR was administered by a head-mounted device displaying nature movies and/or relaxation exercises. The primary endpoint was procedural pain measured using VAS (scale 0.0-10.0 cm). Procedural pain was divided into overall pain score and peak pain score during the procedure. It was measured immediately after HSG. Secondary endpoints included patient satisfaction, VR preferences, and adverse effects of VR. MAIN RESULTS AND THE ROLE OF CHANCE We included a total of 134 women, 69 to the intervention group (HSG with VR) and 65 to the control group (HSG without VR). The mean VAS for peak pain was 6.80 cm (SD 2.25) in the intervention group versus 6.60 cm (SD 2.40) in the control group (mean difference 0.28 (95% CI -0.57, 1.12), P = 0.52). The mean VAS for overall pain was 5.00 cm (SD 2.10) in the intervention group versus 4.90 cm (SD 2.13) in the control group (mean difference 0.06 (95% CI -0.71, 0.84), P = 0.88). The expectation that VR would be a good distraction from pain during HSG was correlated with both overall and peak pain scores. When correcting for this expectation, we found that women in the intervention group reported significantly higher scores, both in peak (adjusted MD 0.58 (95% CI -0.81, 1.97), P = 0.021) and overall (adjusted MD 0.43 (95% CI -0.84, 1.71), P = 0.013) pain, compared to the control group. There were no differences in the prevalence of symptoms that were considered as adverse effects of VR. LIMITATIONS, REASONS FOR CAUTION The study was not blinded. Reasons for declining participation in the study were anxiety or wanting full control during HSG, which might have created selection bias. The distraction score possibly indicates that the level of VR immersiveness was not optimal due to the lack of sound and/or the type of VR applications. Future studies should investigate whether more immersive or interactive VR applications could decrease procedural pain scores during HSG. WIDER IMPLICATIONS OF THE FINDINGS Since VR does not reduce procedural pain, this additional tool should not be used during HSG. STUDY FUNDING/COMPETING INTEREST(S) There was no external funding for this study. KR and AvH report receiving a travel grant from Merck outside the scope of this study. BM is supported by a National Health and Medical Research Council (NHMRC) investigator grant (GNT1176437) and BM reports consultancy for Merck, Organon, and Norgine and travel and research funding from Merck. BM holds stock for ObsEva. CL reports receiving research grants from Merck, and Ferring. KD and VM report receiving travel and speaker's fees from Guerbet and research grants from Guerbet. VM also reports research grants from Merck and Ferring. The remaining authors have nothing to declare. TRIAL REGISTRATION NUMBER The trial is registered prospectively in the Netherlands Trial Register (trialregister.nl registration number NL9203, currently accessible on trialsearch.who.int). TRIAL REGISTRATION DATE 16-01-2021. DATE OF FIRST PATIENT’S ENROLMENT The first participant was enrolled on 19 January 2021.

中文翻译：

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子宫输卵管造影 （HSG） 期间虚拟现实没有缓解疼痛：来自随机对照试验的结果。


研究问题：虚拟现实 （VR） 是减轻子宫输卵管造影 （HSG） 过程中手术疼痛的有效非药物工具吗？总结答案：与没有 VR 的 HSG 相比，带有 VR 的 HSG 不会降低手术疼痛评分。已知的 HSG 通常会让人感到痛苦和不舒服。VR 已被证明可以成功地减轻各种医疗程序和干预期间的急性手术疼痛。研究设计、规模、持续时间 我们在 2021 年 1 月至 2022 年 10 月期间进行了一项双中心、开放标签、随机对照试验。参与者/材料、环境、方法 计划接受 HSG 作为不孕症检查一部分的女性被筛选参与。知情同意后，女性被随机分配到 HSG 联合或不联合 VR 之间。由于干预的性质，该研究没有设盲。VR 由显示自然电影和/或放松练习的头戴式设备进行管理。主要终点是使用 VAS （量表 0.0-10.0 cm） 测量的手术疼痛。手术过程中疼痛分为总体疼痛评分和峰值疼痛评分。在 HSG 后立即测量。次要终点包括患者满意度、 VR 偏好和 VR 的不良反应。主要结果和机会的作用我们共纳入了 134 名女性，其中干预组 69 名（HSG with VR），对照组 65 名（HSG without VR）。干预组峰值疼痛的平均 VAS 为 6.80 cm （SD 2.25），而对照组为 6.60 cm （SD 2.40） （平均差 0.28 （95% CI -0.57， 1.12），P = 0.52）。干预组总体疼痛的平均 VAS 为 5.00 cm （SD 2.10），而对照组为 4.90 cm （SD 2.13） （平均差 0.06 （95% CI -0.71,0.84），P = 0.88）。 预计 VR 可以很好地分散 HSG 期间的疼痛注意力与总体疼痛评分和峰值疼痛评分相关。在校正这一预期时，我们发现干预组的女性报告的疼痛峰值 （调整后 MD 0.58 （95% CI -0.81， 1.97），P = 0.021） 和总体 （调整后 MD 0.43 （95% CI -0.84， 1.71），P = 0.013） 与对照组相比，评分均显著更高。被认为是 VR 不良反应的症状的患病率没有差异。局限性，谨慎的原因 该研究没有设盲。拒绝参与研究的原因是焦虑或希望在 HSG 期间完全控制，这可能造成了选择偏倚。分散注意力分数可能表明，由于缺乏声音和/或 VR 应用程序的类型，VR 沉浸感水平不是最佳的。未来的研究应该调查更具沉浸感或交互式的 VR 应用程序是否可以降低 HSG 期间的手术疼痛评分。研究结果的更广泛意义 由于 VR 不会减轻手术疼痛，因此在 HSG 期间不应使用这种额外的工具。研究资金/竞争利益 本研究没有外部资金。KR 和 AvH 报告说，在本研究的范围之外收到了 Merck 的差旅补助。BM 得到了美国国家健康与医学研究委员会 （NHMRC） 研究者资助 （GNT1176437） 和 BM 报告咨询公司 Merck、Organon 和 Norgine 以及 Merck 的差旅和研究资金的支持。BM 持有 ObsEva 的股票。CL 报告获得了 Merck 和 Ferring 的研究资助。KD 和 VM 报告从 Guerbet 获得了差旅费和演讲费，并从 Guerbet 获得了研究资助。VM 还报告了 Merck 和 Ferring 的研究资助。 其余作者没有什么可声明的。试验注册号 试验在荷兰试验注册处（trialregister.nl 注册号 NL9203，目前可在 trialsearch.who.int 上访问）中前瞻性注册。试验注册日期 2021 年 1 月 16 日。首位患者入组日期 首位参与者于 2021 年 1 月 19 日入组。