Verbal Analgesia During Copper IUD Insertion After Cesarean Delivery

Overview

This open-label, parallel-group randomized controlled trial evaluated whether structured verbal analgesia reduces pain during Copper T380A intrauterine device insertion compared with standardized neutral communication in women with previous cesarean delivery and no prior vaginal birth. Eligible women requesting Copper T380A insertion were randomized in a 1:1 ratio to receive either a structured supportive communication protocol or standardized neutral procedural communication during insertion. The primary outcome was pain intensity measured on a 0-10 numerical rating scale immediately after IUD release in the uterine cavity, with pain at the final attempted insertion step used for failed insertions.

Copper T380A intrauterine device insertion may be associated with procedural pain, particularly in women without prior vaginal birth. Women whose delivery history is limited to cesarean section may experience greater insertion difficulty because the cervix has not undergone the dilation and remodeling associated with vaginal delivery. Nonpharmacological strategies such as structured verbal analgesia may provide a simple, low-cost adjunct for improving the insertion experience. This study was an open-label, parallel-group randomized controlled trial with 1:1 allocation conducted at Algezeera Hospital, Giza, Egypt. Women aged 18-45 years requesting Copper T380A IUD insertion, with previous cesarean delivery and no prior vaginal birth, were randomized to structured verbal analgesia or standardized neutral communication. All participants received oral ibuprofen 600 mg approximately one hour before insertion, and the technical insertion procedure was standardized in both groups. In the structured verbal analgesia group, the provider used calm, supportive, scripted communication with guided breathing and continuous reassurance throughout the procedure. In the standardized neutral communication group, the provider used brief procedural statements only, without additional reassurance, analgesic suggestion, or guided breathing. The primary outcome was pain intensity on a 0-10 numerical rating scale immediately after IUD release in the uterine cavity, or at the final attempted insertion step in failed cases. Secondary outcomes included step-specific pain scores, clinician-rated insertion difficulty, procedure time, failed insertion, vasovagal episode, uterine perforation, rescue analgesia, patient satisfaction, willingness to repeat the procedure, loss to 1-month follow-up, and IUD expulsion at one month. Before study commencement, the final ethics-approved protocol version incorporated amendments made to the originally registered protocol. These amendments were submitted to and approved by the Algezeera Hospital Research Ethics Committee before recruitment, consent, randomization, or any study-related procedure began. During the present ClinicalTrials.gov record update, the registry entry is being aligned with the final ethics-approved protocol version and the completed final study data. These updates do not reflect post-randomization changes to the randomized comparison, participant eligibility, or primary outcome.