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

NCT07031206 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: HSC-MS-25-0136
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety; Pain

Keywords

intrauterine device (IUD) insertion; endometrial biopsy (EMB)

Outcome Measures

Primary Outcomes (1)

• 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

  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

  baseline, and after taking Hydroxyzine about 15-30 mins before procedure

Study Arms (3)

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

Interventions

Paracervical block- Lidocaine without epinephrine DRUG

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.

Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed

Benzocaine Gel applied to the cervix DRUG

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.

Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed

Hydroxyzine Hydrochloride DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• present for an IUD insertion procedure and/or for EMB procedure.

You may not qualify if:

• current Pelvic inflammatory disease (PID)
• contraindications to IUD or EMB
• malignancy
• contraindication to hydroxyzine/Lidocaine/Benzocaine
• positive pregnancy test

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Epinephrine; Hydroxyzine

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pamela Berens, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Berens, MD

CONTACT

(713) 500-6471; Pamela.D.Berens@uth.tmc.edu

Sunbola A Ademola

CONTACT

(713) 500-6410; Sunbola.S.Ashimi@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)