Dumont Sander, Page Ann-Sophie, Dewilde Kobe, Ceusters Jolien, Van Calster Ben, Froyman Wouter, Timmerman Dirk
Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium; Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
Contraception. 2025 Aug;148:110939. doi: 10.1016/j.contraception.2025.110939. Epub 2025 May 8.
This study aimed to assess the patient-reported overall experience when using virtual reality (VR) simulation during intrauterine device (IUD) insertion (primary), the impact of VR in reducing pain, on patient satisfaction, and to assess the difficulty and success of the procedure utilizing VR (secondary).
This was a single-center randomized controlled trial in a Belgian tertiary teaching hospital. Two hundred participants, requesting a levonorgestrel-releasing IUD, were 1:1 computer randomized in either the VR group, where participants wore VR goggles, or in the standard-of-care group. The primary outcome is the patient's overall experience assessed by means of a Visual Analog Scale (VAS; 0-100 mm, continuous, higher is better). A Numeric Pain Rating Scale (0-100, continuous, higher is more pain) was used to address pain during insertion.
In the VR group, 95 participants were included (five were excluded due to failed previous IUD extraction), and in the standard-of-care group, 100 participants were included. There is no evidence for differences in general patient experience (median VAS 72 [intervention] vs 70 [control]; odds ratio [OR] 1.22, 95% CI 0.92-1.61) or pain (median Numeric Pain Rating Scale 50 [intervention] vs 45 [control]; OR 1.04, 95% CI 0.79-1.37) between groups. After 6 weeks, VR-patients reported no evidence for improved general experience (median VAS 70 [intervention] vs 74 [control]; OR 1.09, 95% CI 0.83-1.43) and were less likely to repeat the procedure or recommend it compared to the control group (OR 2.03, 95% CI 1.17-3.56).
VR simulation does not conclusively alter the overall experience or reduce pain, therefore not reducing discomfort during IUD insertion in this randomized controlled trial.
Although VR has already been successfully used in the management of acute pain or during procedures, this study cannot demonstrate improved patient-reported outcomes during the insertion of a levonorgestrel-containing IUD.
本研究旨在评估患者报告的在宫内节育器（IUD）插入过程中使用虚拟现实（VR）模拟的总体体验（主要目的），VR在减轻疼痛方面的作用、对患者满意度的影响，并评估使用VR进行该操作的难度和成功率（次要目的）。
这是一项在比利时一家三级教学医院进行的单中心随机对照试验。200名要求放置左炔诺孕酮宫内节育器的参与者，通过计算机以1:1的比例随机分为VR组（参与者佩戴VR护目镜）或标准治疗组。主要结局是通过视觉模拟量表（VAS；0 - 100毫米，连续变量，分数越高越好）评估的患者总体体验。使用数字疼痛评分量表（0 - 100，连续变量，分数越高疼痛越剧烈）来评估插入过程中的疼痛。
VR组纳入95名参与者（5名因先前取出IUD失败而被排除），标准治疗组纳入100名参与者。没有证据表明两组在总体患者体验（VAS中位数：干预组72 vs 对照组70；优势比[OR] 1.22，95%置信区间0.92 - 1.61）或疼痛（数字疼痛评分量表中位数：干预组50 vs 对照组45；OR 1.04，95%置信区间0.79 - 1.37）方面存在差异。6周后，VR组患者报告没有证据表明总体体验有所改善（VAS中位数：干预组70 vs 对照组74；OR 1.09，95%置信区间0.83 - 1.43），并且与对照组相比，他们重复该操作或推荐该操作的可能性更小（OR 2.03，95%置信区间1.17 - 3.56）。
VR模拟并不能决定性地改变总体体验或减轻疼痛，因此在这项随机对照试验中，它并不能减轻IUD插入过程中的不适感。
尽管VR已成功应用于急性疼痛管理或手术过程中，但本研究未能证明在放置含左炔诺孕酮宫内节育器过程中患者报告的结局有所改善。
