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Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women With Previous Cesarean Delivery
Sponsor: Cairo University
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2025-10-02
Completion Date
2026-02-28
Last Updated
2026-01-08
Healthy Volunteers
Yes
Conditions
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
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
Locations (1)
Al Gezeera Hospital
Giza, Egypt