Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women With Previous Cesarean Delivery

NCT07326007 | Recruiting

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

Brief Summary

Insertion of copper IUDs is often associated with moderate pain, which may reduce acceptance and continuation rates. Factors such as nulliparity and absence of prior vaginal delivery are known to increase pain perception. Women who have delivered only by cesarean section represent a special subgroup because their cervix has not undergone vaginal dilation and cervical remodeling, making insertion technically more difficult and often more painful. This group has been underrepresented in prior analgesia trials, highlighting an important evidence gap.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• pain during IUD insertion

  Pain intensity measured by a 0-10 Numerical Rating Scale (NRS) immediately after IUD release in the uterine cavity, where 0 = "no pain" and 10 = "worst pain imaginable

  immediately after IUD insertion. at the time if IUD release into the uterine cavity

Secondary Outcomes (2)

• Clinician-rated ease of insertion

  Immediately after completion of IUD insertion procedure

• Patient satisfaction

  at the end of procedure before discharge from clinic

Study Arms (2)

Verbal Analgesia

EXPERIMENTAL

Participants randomized to the verbal analgesia group will receive a structured communication protocol delivered by the provider throughout the IUD insertion procedure.participants will receive a structured verbal analgesia technique delivered by the provider throughout the IUD insertion procedure. The method involves using a calm, low-volume voice with steady pitch and a slow rate of speech, maintaining a non-rushed and empathetic manner intended to reduce patient anxiety and modulate pain perception. The communication is scripted to ensure consistency. Before beginning, the provider reassures the patient by saying: "You are safe here; I will guide you through every step. Please take slow, deep breaths with me." During speculum insertion, the provider continues: "You may feel some pressure now; that's normal. Keep breathing slowly." At the time of tenaculum application, the patient is prepared with: "You will feel a pinch on the cervix; it may be uncomfortable, but it will pass quick

Behavioral: Verbal Analgesia

Control - Standard Technique

ACTIVE COMPARATOR

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 complete"), delivered without reassurance or supportive phrasing

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

Participants randomized to the verbal analgesia group will receive a structured communication protocol delivered by the provider throughout the IUD insertion procedure.participants will receive a structured verbal analgesia technique delivered by the provider throughout the IUD insertion procedure. The method involves using a calm, low-volume voice with steady pitch and a slow rate of speech, maintaining a non-rushed and empathetic manner intended to reduce patient anxiety and modulate pain perception. The communication is scripted to ensure consistency. Before beginning, the provider reassures the patient by saying: "You are safe here; I will guide you through every step. Please take slow, deep breaths with me." During speculum insertion, the provider continues: "You may feel some pressure now; that's normal. Keep breathing slowly." At the time of tenaculum application, the patient is prepared with: "You will feel a pinch on the cervix; it may be uncomfortable, but it will pass quickl

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

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 complete"), delivered without reassurance or supportive phrasing

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.
• Desire for Copper T380A IUD.
• Delivery history limited to cesarean section(s), no vaginal delivery

You may not qualify if:

• o Current pelvic infection, cervicitis, or vaginitis.
• Uterine anomalies or fibroids distorting the cavity.
• Contraindication to copper IUD procedure, and use of any analgesic medication within the last 6-8 hours prior to insertion.
• Pregnancy or suspected pregnancy.
• Severe dysmenorrhea requiring narcotics

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al Gezeera Hospital

Giza, Egypt

RECRUITING

Central Study Contacts

Mahmoud Alalfy

CONTACT

+201002611058; mahmoudalalfy@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• 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 2, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 28, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

EG (1)