Intrauterine devices (IUDs), including copper and levonorgestrel-releasing intrauterine systems (LNG-IUS), are effective contraceptive methods with few contraindications [1], [2], [3], [4]. However, worldwide the use of IUDs representing only 17% of the contraceptives used [5]. The pain frequently felt during IUD insertion may limit the use of IUDs [2,6]. Pain is defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage" [7]. During IUD insertion, the pain varies from that equivalent to "menstrual pain" to intolerable pain, with higher intensity pain often observed in nulliparous women [3,[8], [9], [10], [11]]. Dysmenorrhea has been shown to predict pain during IUD insertions [8].

Several pharmacological treatments to reduce the pain associated with the insertions of IUDs have been assessed. Studies assessing naproxen and tramadol in this setting have yielded conflicting results [12], [13], [14], [15]. Moreover, a meta-analysis concluded that misoprostol, lidocaine gel (2%), and most non-steroidal anti-inflammatory drugs did not alleviate pain during IUDs insertion [16].

Non-pharmacological treatments have been implemented, with varying effectiveness, for alleviating pain, for example during labour and childbirth,[17] during orthopaedic surgeries, [18] and for procedural pain during burn wound care. [19] Virtual reality (VR) devices are distraction tools, that consists of a 360° virtual environment with a tracking device for the user's head. This combination induces the illusion of being totally immersed in a virtual world. The recent emergence of these devices has sparked interest in VR therapy as a non-invasive tool for pain management [20], [21], [22], [23], [24], [25], [26], [27]. Current evidence suggests that VR therapy may be effective in reducing pain during medical procedures, but the results are inconclusive.

To our knowledge no study has yet assessed the use of VR therapy to alleviate pain during IUDs insertion. Therefore, we conducted a bi-centric, randomized, open-label trial to investigate the effects of VR therapy used during the procedure on the pain and anxiety induced by IUD insertion. The primary objective was to compare the pain experienced by women during IUD insertions, with or without VR therapy. Secondary objectives compared the anxiety experienced during the IUD insertions, as well as women's satisfaction with the IUD insertions, with or without VR therapy.