Study of Using Menstrual Disc or Cervical Cap to Apply Topical Anesthetic Before IUD Insertion in Women

What this Trial Is About

This study involves nulliparous women planning to have an intrauterine device IUD placed without sedation or anxiety medication at the Center for Womens Health. The research aims to evaluate two methods of applying a topical anesthetic cream, EMLA, using either a menstrual disc or a cervical cap, to reduce pain during IUD insertion. The study is open label, randomized, and designed to assess the feasibility of these application methods. Participants will be randomly assigned to one of two groups one group will self-administer 5g of EMLA cream using a menstrual disc, and the other group will use a cervical cap filled with the same anesthetic cream. Study staff will ensure proper placement of the disc or cap, set a seven-minute timer, and then remove the device before the provider inserts the IUD according to manufacturer instructions. There are 12 participants in each group. Throughout the procedure, pain will be measured using a Visual Analog Scale VAS, and both participants and providers will report on pain levels, side effects, and any complications immediately after the procedure. Additional outcomes include ease of device placement, protocol deviations, menstrual pain before the procedure, and acceptability of pain management one day after. The study will monitor successful IUD placement and satisfaction with pain control, and participation will last through the procedure and immediate post-procedure assessments.

Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion