Verbal Analgesia During Copper IUD Insertion After Cesarean Delivery

NCT07326007 | Completed

• 1 other identifier: verbal analgesia IUD
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Pain intensity at IUD release

  Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain was recorded immediately after release of the Copper T380A IUD into the uterine cavity. In failed insertion cases, pain at the final attempted insertion step was used as the prespecified primary-outcome substitute.

  Immediately after IUD release in the uterine cavity, or immediately after the final attempted insertion step in failed cases.

Secondary Outcomes (6)

• Clinician-rated insertion difficulty

  Immediately after completion or termination of the IUD insertion procedure.

• Patient satisfaction

  at the end of procedure before discharge from clinic

• Pain after speculum insertion

  Immediately after speculum insertion.

• Pain after tenaculum application

  Immediately after tenaculum application.

• Pain after uterine sounding

  Immediately after uterine sounding.

Study Arms (2)

Verbal Analgesia

EXPERIMENTAL

Participants randomized to the structured verbal analgesia group received a standardized supportive communication protocol throughout Copper T380A IUD insertion. The provider used a calm, low-volume voice, steady pitch, slow rate of speech, guided breathing, and continuous reassurance. The script was delivered at defined procedural steps, including before speculum insertion, during tenaculum application, during uterine sounding, during IUD insertion, and after completion of the procedure. The technical insertion procedure was otherwise identical to the control group.

Behavioral: Verbal Analgesia

Control - Standard Technique

ACTIVE COMPARATOR

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.

Behavioral: 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

Interventions

Verbal Analgesia BEHAVIORAL

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.

Verbal Analgesia

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 BEHAVIORAL

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.

Control - Standard Technique

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45 years.
• Requesting Copper T380A intrauterine device insertion.
• Delivery history limited to cesarean section(s), with no prior vaginal delivery.
• Regular menstrual cycles.
• Eligible for Copper T380A IUD insertion according to World Health Organization medical eligibility criteria.
• Able to provide written informed consent.

You may not qualify if:

• Current pelvic infection, cervicitis, or vaginitis.
• Uterine anomalies or fibroids distorting the uterine cavity.
• Any contraindication to Copper T380A IUD insertion.
• Contraindication to ibuprofen.
• Use of analgesic medication within 6-8 hours before insertion.
• Pregnancy or suspected pregnancy.
• Severe dysmenorrhea requiring narcotic analgesia.

Sponsors & Collaborators

• Cairo University: lead
• Algazeera Hospital: collaborator

Study Sites (1)

Algezeera Hospital

Giza, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking of participants and providers was not feasible because the intervention consisted of the manner and content of verbal communication during the procedure. To reduce bias, both intervention and control scripts were standardized. Pain scores were recorded immediately after the relevant procedural step using a standardized 0-10 numerical rating scale by study personnel not involved in delivering the intervention; however, because the communication style was audible, outcome assessment could not be considered fully blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: January 8, 2026
• Study Start: October 10, 2025
• Primary Completion: April 10, 2026
• Study Completion: May 10, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

EG (1)