Verbal Analgesia During Copper IUD Insertion After Cesarean Delivery

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Behavioral: Verbal Analgesia; 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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Algezeera Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verbal Analgesia; 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; 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.
Active Comparator: Control - Standard Technique; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	It will be measured usinga 0-10 NRS-like scale at the end of the visit, where 0 = no satisfaction and 10 = maximum satisfaction	at the end of procedure before discharge from clinic
Clinician-rated insertion difficulty	Insertion difficulty rated by the clinician using a 0-10 scale, where 0 indicates very easy insertion and 10 indicates the most difficult insertion.	Immediately after completion or termination of the IUD insertion procedure.
Pain after speculum insertion	Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.	Immediately after speculum insertion.
Pain after tenaculum application	Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.	Immediately after tenaculum application.
Pain after uterine sounding	Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.	Immediately after uterine sounding.
Procedure time	Procedure time measured in minutes from speculum insertion to IUD placement and string trimming, or to termination of the final insertion attempt in failed cases.	During the IUD insertion procedure.

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Algazeera Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): May 10, 2026

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: verbal analgesia IUD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No