Contraception
Conditions
Brief summary
This open-label, parallel-group randomized controlled trial evaluated whether structured verbal analgesia reduces pain during Copper T380A intrauterine device insertion compared with standardized neutral communication in women with previous cesarean delivery and no prior vaginal birth. Eligible women requesting Copper T380A insertion were randomized in a 1:1 ratio to receive either a structured supportive communication protocol or standardized neutral procedural communication during insertion. The primary outcome was pain intensity measured on a 0-10 numerical rating scale immediately after IUD release in the uterine cavity, with pain at the final attempted insertion step used for failed insertions.
Detailed description
Copper T380A intrauterine device insertion may be associated with procedural pain, particularly in women without prior vaginal birth. Women whose delivery history is limited to cesarean section may experience greater insertion difficulty because the cervix has not undergone the dilation and remodeling associated with vaginal delivery. Nonpharmacological strategies such as structured verbal analgesia may provide a simple, low-cost adjunct for improving the insertion experience. This study was an open-label, parallel-group randomized controlled trial with 1:1 allocation conducted at Algezeera Hospital, Giza, Egypt. Women aged 18-45 years requesting Copper T380A IUD insertion, with previous cesarean delivery and no prior vaginal birth, were randomized to structured verbal analgesia or standardized neutral communication. All participants received oral ibuprofen 600 mg approximately one hour before insertion, and the technical insertion procedure was standardized in both groups. In the structured verbal analgesia group, the provider used calm, supportive, scripted communication with guided breathing and continuous reassurance throughout the procedure. In the standardized neutral communication group, the provider used brief procedural statements only, without additional reassurance, analgesic suggestion, or guided breathing. The primary outcome was pain intensity on a 0-10 numerical rating scale immediately after IUD release in the uterine cavity, or at the final attempted insertion step in failed cases. Secondary outcomes included step-specific pain scores, clinician-rated insertion difficulty, procedure time, failed insertion, vasovagal episode, uterine perforation, rescue analgesia, patient satisfaction, willingness to repeat the procedure, loss to 1-month follow-up, and IUD expulsion at one month. Before study commencement, the final ethics-approved protocol version incorporated amendments made to the originally registered protocol. These amendments were submitted to and approved by the Algezeera Hospital Research Ethics Committee before recruitment, consent, randomization, or any study-related procedure began. During the present ClinicalTrials.gov record update, the registry entry is being aligned with the final ethics-approved protocol version and the completed final study data. These updates do not reflect post-randomization changes to the randomized comparison, participant eligibility, or primary outcome.
Interventions
BEHAVIORALVerbal Analgesia
Structured verbal analgesia consisted of a scripted supportive communication protocol delivered by the provider throughout IUD insertion. The protocol used calm tone, slow speech, guided breathing, reassurance, and positive procedural framing at predefined steps. No additional pharmacologic analgesic intervention was given beyond the standard pre-procedure ibuprofen used in both groups.
BEHAVIORALProviders 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
Participants randomized to the standardized neutral communication group received brief procedural statements only during Copper T380A IUD insertion, such as "I am now placing the speculum," "I am sounding the uterus," "The IUD is being inserted," and "The procedure is complete." The provider did not use additional reassurance, analgesic suggestion, guided breathing, or structured supportive phrasing. The technical insertion procedure was otherwise identical to the verbal analgesia group.
Sponsors
Cairo University
Algazeera Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Masking of participants and providers was not feasible because the intervention consisted of the manner and content of verbal communication during the procedure. To reduce bias, both intervention and control scripts were standardized. Pain scores were recorded immediately after the relevant procedural step using a standardized 0-10 numerical rating scale by study personnel not involved in delivering the intervention; however, because the communication style was audible, outcome assessment could not be considered fully blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18-45 years. * Requesting Copper T380A intrauterine device insertion. * Delivery history limited to cesarean section(s), with no prior vaginal delivery. * Regular menstrual cycles. * Eligible for Copper T380A IUD insertion according to World Health Organization medical eligibility criteria. * Able to provide written informed consent.
Exclusion criteria
* Current pelvic infection, cervicitis, or vaginitis. * Uterine anomalies or fibroids distorting the uterine cavity. * Any contraindication to Copper T380A IUD insertion. * Contraindication to ibuprofen. * Use of analgesic medication within 6-8 hours before insertion. * Pregnancy or suspected pregnancy. * Severe dysmenorrhea requiring narcotic analgesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at IUD release | Immediately after IUD release in the uterine cavity, or immediately after the final attempted insertion step in failed cases. | Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain was recorded immediately after release of the Copper T380A IUD into the uterine cavity. In failed insertion cases, pain at the final attempted insertion step was used as the prespecified primary-outcome substitute. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-rated insertion difficulty | Immediately after completion or termination of the IUD insertion procedure. | Insertion difficulty rated by the clinician using a 0-10 scale, where 0 indicates very easy insertion and 10 indicates the most difficult insertion. |
| Patient satisfaction | at the end of procedure before discharge from clinic | It will be measured usinga 0-10 NRS-like scale at the end of the visit, where 0 = no satisfaction and 10 = maximum satisfaction |
| Pain after speculum insertion | Immediately after speculum insertion. | Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| Pain after tenaculum application | Immediately after tenaculum application. | Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| Pain after uterine sounding | Immediately after uterine sounding. | Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| Procedure time | During the IUD insertion procedure. | Procedure time measured in minutes from speculum insertion to IUD placement and string trimming, or to termination of the final insertion attempt in failed cases. |
Countries
Egypt
Outcome results
None listed