ContraceptionNCT07326007
Verbal Analgesia During Copper IUD Insertion After Cesarean Delivery
A study testing Verbal Analgesia and 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 in people with Contraception, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Verbal Analgesia and 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 10 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structured Verbal Analgesia Versus Neutral Communication During Copper T380A IUD Insertion in Women With Previous Cesarean Delivery and No Prior Vaginal Birth: An Open-Label Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Verbal Analgesia, 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal AnalgesiaBehavioural
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.
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 completBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Verbal Analgesia | Experimental | Participants randomized to the structured verbal analgesia group received a standardized supportive communication protocol throughout Copper T380A IUD insertion. The provider used a calm, low-volume voice, steady pitch, slow rate of speech, guided breathing, and continuous reassurance. The script was delivered at defined procedural steps, including before speculum insertion, during tenaculum application, during uterine sounding, during IUD insertion, and after completion of the procedure. The technical insertion procedure was otherwise identical to the control group. Receives: Behavioral: Verbal Analgesia |
| Control - Standard Technique | Active comparator | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at IUD release
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.
Measured: Immediately after IUD release in the uterine cavity, or immediately after the final attempted insertion step in failed cases.
Secondary outcomes (6)
Clinician-rated insertion difficulty
Insertion difficulty rated by the clinician using a 0-10 scale, where 0 indicates very easy insertion and 10 indicates the most difficult insertion.
Measured: Immediately after completion or termination of the IUD insertion procedure.
Patient satisfaction
It will be measured usinga 0-10 NRS-like scale at the end of the visit, where 0 = no satisfaction and 10 = maximum satisfaction
Measured: at the end of procedure before discharge from clinic
Pain 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.
Measured: Immediately after speculum insertion.
Pain 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.
Measured: Immediately after tenaculum application.
Pain 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.
Measured: Immediately after uterine sounding.
Procedure time
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.
Measured: During the IUD insertion procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start10 Oct 2025
- Primary completion10 Apr 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Algazeera Hospital
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326007
- Sponsor's protocol ID
- verbal analgesia IUD
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Verbal Analgesia Versus Neutral Communication During Copper T380A IUD Insertion in Women With Previous Cesarean Delivery and No Prior Vaginal Birth: An Open-Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07326007
- Acronym / sponsor ID
- verbal analgesia IUD
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Algazeera Hospital
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal Analgesia | Experimental | Behavioral: Verbal AnalgesiaParticipants randomized to the structured verbal analgesia group received a standardized supportive communication protocol throughout Copper T380A IUD insertion. The provider used a calm, low-volume voice, steady pitch, slow rate of speech, guided breathing, and continuous reassurance. The script was delivered at defined procedural steps, including before speculum insertion, during tenaculum application, during uterine sounding, during IUD insertion, and after completion of the procedure. The technical insertion procedure was otherwise identical to the control group. |
| Control - Standard Technique | Active comparator | 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 completParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal AnalgesiaStructured 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. | Behavioural | Verbal Analgesia |
| 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 completParticipants 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. | Behavioural | Control - Standard Technique |
Primary outcome
Pain intensity at IUD release
Time frame: 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.
6 secondary outcomes
Clinician-rated insertion difficulty
Time frame: Immediately after completion or termination of the IUD insertion procedure.
Patient satisfaction
Time frame: at the end of procedure before discharge from clinic
Pain after speculum insertion
Time frame: Immediately after speculum insertion.
Pain after tenaculum application
Time frame: Immediately after tenaculum application.
Pain after uterine sounding
Time frame: Immediately after uterine sounding.
Procedure time
Time frame: During the IUD insertion procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal Analgesia and 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 in people with Contraception, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at IUD release (time frame: Immediately after IUD release in the uterine cavity, or immediately after the final attempted insertion step in failed cases.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.