University of Rennes, CHU Rennes, Department of General Practice, 2 Av. du Professeur Léon Bernard, F-35000 Rennes, France.
University of Rennes, CHU Rennes, Department of General Practice, 2 Av. du Professeur Léon Bernard, F-35000 Rennes, France.
J Gynecol Obstet Hum Reprod. 2024 Jan;53(1):102706. doi: 10.1016/j.jogoh.2023.102706. Epub 2023 Nov 25.
The trial aimed to compare the pain perceived by women during intrauterine device (IUD) insertion, with or without virtual reality (VR) therapy. Furthermore, anxiety during the insertions, pain after the insertions, and satisfaction with the insertions were compared.
The trial was designed as a prospective, bi-centric, randomized, open-label interventional trial. All adult women that chose an IUD during a contraceptive consultation, and who provided informed consent were eligible. Women under legal guardianship, not affiliated to a national social security system, and with pre-existing dizziness, severe facial wounds, or epilepsy were not eligible. Eligible women were randomly allocated either standard care without VR therapy (Control group) or with VR therapy (Experimental group). Pain, anxiety, and satisfaction were measured using a 10-cm numerical scale.
Between September 2020 and April 2022, 100 women were randomized: 50 to each group. The mean pain scores during IUD insertion were 5.4 cm in the Control group versus 5.1 cm in the Experimental group (p = 0.54). Mean anxiety during insertion were 4.8 cm in the Control group versus 4.2 cm in the Experimental group (p = 0.13). While mean pain perceived after insertions were 2.4 cm in the Control Group and 2.4 cm in the Experimental group (p = 0.98). Mean satisfaction with the insertions was 9.6 cm in both groups (p = 0.87). Anxiety before IUD insertion, as well as anticipated pain, were significantly correlated with pain perceived during insertions.
VR therapy performed during the procedure did not alleviate perceived pain in women undergoing IUD insertions.
本试验旨在比较有虚拟现实（VR）治疗和无 VR 治疗的情况下，宫内节育器（IUD）放置过程中女性感知到的疼痛。此外，还比较了放置过程中的焦虑、放置后的疼痛以及对放置的满意度。
本试验设计为前瞻性、双中心、随机、开放标签的干预性试验。所有在避孕咨询期间选择 IUD 并提供知情同意的成年女性均符合条件。不隶属于国家社会保障体系的受法律监护的女性，以及有头晕、严重面部伤口或癫痫病史的女性不符合条件。符合条件的女性被随机分配至标准护理（无 VR 治疗）组（对照组）或 VR 治疗组（实验组）。使用 10cm 数字量表测量疼痛、焦虑和满意度。
2020 年 9 月至 2022 年 4 月，共随机分配 100 名女性：每组 50 名。对照组 IUD 放置过程中的平均疼痛评分（VAS）为 5.4cm，实验组为 5.1cm（p=0.54）。对照组插入时的平均焦虑评分为 4.8cm，实验组为 4.2cm（p=0.13）。对照组放置后感知的平均疼痛为 2.4cm，实验组为 2.4cm（p=0.98）。两组对插入的平均满意度均为 9.6cm（p=0.87）。IUD 插入前的焦虑以及预期疼痛与插入过程中的疼痛感知显著相关。
在 IUD 放置过程中进行 VR 治疗并不能减轻女性感知到的疼痛。
