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Investigating Pre-Procedural Anxiety and Effect of Analgesia on Intrauterine Device Placement and Endometrial Biopsy

NCT07031206 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-06-22

No results posted yet for this study

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 patient population, undergoing IUD insertion/EMB procedure at the end of our study.

Conditions

Interventions

DRUG

Paracervical block- Lidocaine without epinephrine

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.

DRUG

Benzocaine Gel applied to the cervix

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.

DRUG

Hydroxyzine Hydrochloride

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Pamela Berens, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-05-05
Completion
2026-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07031206 on ClinicalTrials.gov