NCT07326007

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

Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women With Previous Cesarean Delivery: An Open-Label Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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
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

Timeline

• Start date: 2025-10-02
• Primary completion: 2026-02-15
• Completion: 2026-02-28
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Egypt