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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:
• Women aged 18-45 years.
‣ Desire for Copper T380A IUD.
⁃ Delivery history limited to cesarean section(s), no vaginal delivery
Locations
Other Locations
Egypt
Al Gezeera Hospital
RECRUITING
Giza
Contact Information
Primary
Mahmoud Alalfy
mahmoudalalfy@ymail.com
+201002611058
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 88
Treatments
Experimental: 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
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Cairo University