Structured Verbal Analgesia Versus Neutral Communication During Copper T380A IUD Insertion in Women with Previous Cesarean Delivery and No Prior Vaginal Birth: An Open-Label Randomized Controlled Trial

Background & Objective: Women with previous cesarean delivery and no prior vaginal birth may have more difficult and painful intrauterine device insertion, highlighting the need for simple non-pharmacologic pain-reduction strategies. The present study aimed to compare structured verbal analgesia vs. standardized neutral communication during Copper T380A intrauterine device insertion in women with previous cesarean delivery and no prior vaginal birth. Materials & Methods: This open-label, parallel-group, randomized controlled trial with 1:1 allocation to structured verbal analgesia or standardized neutral communication, was conducted in the outpatient family planning and gynecology clinic of a tertiary referral hospital in Egypt from October 2025 to May 2026. Women aged 18-45 years who had delivered only by CD, with no prior vaginal birth, and who requested Copper T380A insertion were enrolled. Insertion technique was the same in both arms. The primary outcome was pain on a 0-10 numerical rating scale, recorded immediately after IUD release or, in failed insertions, at the final attempted step. Analyses were performed using MedCalc statistical software (version 22.0). P<0.05 was considered significant. Results: Eighty-eight women were randomized, 44 to each group. Pain at IUD release or final attempted insertion did not differ significantly between the two groups of structured verbal analgesia and standardized neutral communication (4.8±1.8 vs 5.2±1.9; mean difference -0.36; 95% CI, -1.16 to 0.43; P=0.36). Step-specific pain scores, clinician-rated insertion difficulty, and procedure time were comparable. Failed insertion occurred in 1 woman (2.3%) in the verbal analgesia group and 2 women (4.5%) in the neutral communication group. Rescue analgesia, satisfaction, willingness to repeat the procedure, and vasovagal episodes were also similar. No uterine perforation occurred. At 1 month, expulsion occurred in 1/41(2.4%) of the verbal analgesia group versus 1/39(2.6%) of the neutral communication group with completed follow-up. Conclusion: Structured verbal analgesia did not significantly reduce Copper T380A insertion pain compared with standardized neutral communication. Larger trials are needed to determine whether smaller patient-important benefits exist.