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

Cairo University (CU)

Status: Enrolling

Conditions: Contraception

Treatments: Behavioral: Verbal Analgesia; 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07326007

verbal analgesia IUD-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 88 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Verbal Analgesia

Experimental group

Description:

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

Treatment:

Behavioral: Verbal Analgesia

Control - Standard Technique

Active Comparator group

Description:

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

Treatment:

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