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

NCT ID: NCT07326007

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-02
• Study Completion Date: 2026-02-28

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.

Detailed Description

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.

Pharmacological interventions (NSAIDs, opioids, local anesthetics) have shown inconsistent results. A randomized controlled trial demonstrated that verbal analgesia, using calm voice, reassurance, and continuous communication, was as effective as tramadol for IUD insertion among nulliparous women. To date, no randomized study has specifically addressed women delivered only by cesarean section

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Verbal Analgesia

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

Group Type: EXPERIMENTAL

Verbal Analgesia

Intervention Type: 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

Control - Standard Technique

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

Group Type: 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 complet

Intervention Type: 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

Interventions

Verbal Analgesia

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

Intervention Type: 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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women aged 18-45 years.

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al Gezeera Hospital

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud Alalfy

Role: CONTACT

mahmoudalalfy@ymail.com

+201002611058

Facility Contacts

mahmoud alalfy

Role: primary

Other Identifiers

verbal analgesia IUD-1

Identifier Type: -

Identifier Source: org_study_id