AnxietyPhase 2NCT07031206
Investigating Pre-Procedural Anxiety and Effect of Analgesia on Intrauterine Device Placement and Endometrial Biopsy
A Phase 2 study testing Paracervical block- Lidocaine without epinephrine, Benzocaine Gel applied to the cervix and Hydroxyzine Hydrochloride in people with Anxiety and Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate pre-procedural anxiety and patient pain perception with IUD insertion/ EMB procedure when using analgesia versus no analgesia by the end of the study and to evaluate the effect of age, race, parity, type of IUD and anxiety on pain and to offer better pain management in our… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Paracervical block- Lidocaine without epinephrine, Benzocaine Gel applied to the cervix and Hydroxyzine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 5 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- present for an IUD insertion procedure and/or for EMB procedure.
Who cannot join
- current Pelvic inflammatory disease (PID)
- contraindications to IUD or EMB
- malignancy
- contraindication to hydroxyzine/Lidocaine/Benzocaine
- positive pregnancy test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Pamela Berens, MD, 713-500-6471, Pamela.D.Berens@uth.tmc.edu
Sunbola A Ademola, (713) 500-6410, Sunbola.S.Ashimi@uth.tmc.edu
About this study
The purpose of this study is to evaluate pre-procedural anxiety and patient pain perception with IUD insertion/ EMB procedure when using analgesia versus no analgesia by the end of the study and to evaluate the effect of age, race, parity, type of IUD and anxiety on pain and to offer better pain management in our patient population, undergoing IUD insertion/EMB procedure at the end of our study.
- Being tested
- Paracervical block- Lidocaine without epinephrine, Benzocaine Gel applied to the cervix, Hydroxyzine Hydrochloride
- Keywords
- intrauterine device (IUD) insertion, endometrial biopsy (EMB)
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracervical block- Lidocaine without epinephrineDrug
1-2 cc of Lidocaine at the tenaculum site on the cervix at 12 o-clock will be injected after pain scale #1 is completed. Pain scale #2 will be done then 3 cc of 1% lidocaine at 4 and 8 o'clock position of the cervix will be administered. The IUD insertion or EMB will be performed nd pain scale #3 will be done.
Benzocaine Gel applied to the cervixDrug
After pain scale #1 is performed , topical benzocaine will be applied to the cervix with Procto swabs and this will be allowed to remain on cervix for 203 minutes. Then Betadine will be applied to the cervix and surrounding vaginal tissue followed by pain scale #2. IUD insertion or EMB will be done followed by pain scale #3.
Hydroxyzine HydrochlorideDrug
Preprocedure, a GAD 7 scoring will be performed to determine level of anxiety. If > 10 indicating Moderate anxiety, participants will be offered pretreatment with Anxiolytic (Hydroxyzine 25mg) approximately 15-20 mins before procedure. If this is done at the preceding visit, participants will be sent home with a prescription for hydroxyzine to be taken 10-15 mins before the procedure when participants are brought back for procedure visit.
| Study group | Role | What they receive |
|---|---|---|
| Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed | Experimental | Not described Receives: Drug: Paracervical block- Lidocaine without epinephrine; Drug: Hydroxyzine Hydrochloride |
| Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed | Experimental | Not described Receives: Drug: Benzocaine Gel applied to the cervix; Drug: Hydroxyzine Hydrochloride |
| No analgesia with Hydroxyzine hydrochloride if needed | Experimental | Not described Receives: Drug: Hydroxyzine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain perception during IUD insertion as assessed by the Faces Pain Visual Analogue Scale (VAS)
VAS is scored from 1-10, higher score indicating greater pain
Measured: baseline (with the speculum in place before pain management procedures), after tenaculum placement (but before IUD placement or EMB) and immediately after IUD insertion or EMB.
Secondary outcomes (1)
Change in anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) scale
Measured: baseline, and after taking Hydroxyzine about 15-30 mins before procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion5 May 2026 (estimated)
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Berens, The University of Texas Health Science Center, Houston
- Investigators
- Pamela Berens, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031206
- Sponsor's protocol ID
- HSC-MS-25-0136
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Pre-Procedural Anxiety and Effect of Analgesia on Intrauterine Device Placement and Endometrial Biopsy
- ClinicalTrials.gov ID
- NCT07031206
- Acronym / sponsor ID
- HSC-MS-25-0136
- Keywords
- intrauterine device (IUD) insertion, endometrial biopsy (EMB)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 22 Jun 2025 (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.
The purpose of this study is to evaluate pre-procedural anxiety and patient pain perception with IUD insertion/ EMB procedure when using analgesia versus no analgesia by the end of the study and to evaluate the effect of age, race, parity, type of IUD and anxiety on pain and to offer better pain management in our patient population, undergoing IUD insertion/EMB procedure at the end of our study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed | Experimental | Drug: Paracervical block- Lidocaine without epinephrine, Drug: Hydroxyzine Hydrochloride |
| Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed | Experimental | Drug: Benzocaine Gel applied to the cervix, Drug: Hydroxyzine Hydrochloride |
| No analgesia with Hydroxyzine hydrochloride if needed | Experimental | Drug: Hydroxyzine Hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- present for an IUD insertion procedure and/or for EMB procedure.
Key exclusion criteria (5 listed)
- current Pelvic inflammatory disease (PID)
- contraindications to IUD or EMB
- malignancy
- contraindication to hydroxyzine/Lidocaine/Benzocaine
- positive pregnancy test
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 |
|---|---|---|
| Paracervical block- Lidocaine without epinephrine1-2 cc of Lidocaine at the tenaculum site on the cervix at 12 o-clock will be injected after pain scale #1 is completed. Pain scale #2 will be done then 3 cc of 1% lidocaine at 4 and 8 o'clock position of the cervix will be administered. The IUD insertion or EMB will be performed nd pain scale #3 will be done. | Drug | Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed |
| Benzocaine Gel applied to the cervixAfter pain scale #1 is performed , topical benzocaine will be applied to the cervix with Procto swabs and this will be allowed to remain on cervix for 203 minutes. Then Betadine will be applied to the cervix and surrounding vaginal tissue followed by pain scale #2. IUD insertion or EMB will be done followed by pain scale #3. | Drug | Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed |
| Hydroxyzine HydrochloridePreprocedure, a GAD 7 scoring will be performed to determine level of anxiety. If > 10 indicating Moderate anxiety, participants will be offered pretreatment with Anxiolytic (Hydroxyzine 25mg) approximately 15-20 mins before procedure. If this is done at the preceding visit, participants will be sent home with a prescription for hydroxyzine to be taken 10-15 mins before the procedure when participants are brought back for procedure visit. | Drug | Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed, No analgesia with Hydroxyzine hydrochloride if needed, Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed |
Primary outcome
Change in pain perception during IUD insertion as assessed by the Faces Pain Visual Analogue Scale (VAS)
Time frame: baseline (with the speculum in place before pain management procedures), after tenaculum placement (but before IUD placement or EMB) and immediately after IUD insertion or EMB.
VAS is scored from 1-10, higher score indicating greater pain
1 secondary outcome
Change in anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) scale
Time frame: baseline, and after taking Hydroxyzine about 15-30 mins before procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Pamela Berens, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paracervical block- Lidocaine without epinephrine, Benzocaine Gel applied to the cervix and Hydroxyzine Hydrochloride in people with Anxiety and Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jun 2025. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Berens, MD ((713) 500-6471, Pamela.D.Berens@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain perception during IUD insertion as assessed by the Faces Pain Visual Analogue Scale (VAS) (time frame: baseline (with the speculum in place before pain management procedures), after tenaculum placement (but before IUD placement or EMB) and immediately after IUD insertion or EMB.). 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 22 Jun 2025.