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Verbal Analgesia During Copper IUD Insertion After Cesarean Delivery
Sponsor: Cairo University
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2025-10-10
Completion Date
2026-05-10
Last Updated
2026-06-10
Healthy Volunteers
Yes
Conditions
Interventions
Verbal Analgesia
Structured verbal analgesia consisted of a scripted supportive communication protocol delivered by the provider throughout IUD insertion. The protocol used calm tone, slow speech, guided breathing, reassurance, and positive procedural framing at predefined steps. No additional pharmacologic analgesic intervention was given beyond the standard pre-procedure ibuprofen used in both groups.
Providers will use a standardized neutral script with brief instructions only (e.g., "I am now placing the speculum," "I am sounding the uterus," "The IUD is being inserted," "The procedure is complet
Participants randomized to the standardized neutral communication group received brief procedural statements only during Copper T380A IUD insertion, such as "I am now placing the speculum," "I am sounding the uterus," "The IUD is being inserted," and "The procedure is complete." The provider did not use additional reassurance, analgesic suggestion, guided breathing, or structured supportive phrasing. The technical insertion procedure was otherwise identical to the verbal analgesia group.
Locations (1)
Algezeera Hospital
Giza, Egypt