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

NCT ID: NCT07031206

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-05-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed

Group Type: EXPERIMENTAL

Paracervical block- Lidocaine without epinephrine

Intervention Type: 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.

Hydroxyzine Hydrochloride

Intervention Type: 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

Group Type: EXPERIMENTAL

Benzocaine Gel applied to the cervix

Intervention Type: 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.

Hydroxyzine Hydrochloride

Intervention Type: 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.

No analgesia with Hydroxyzine hydrochloride if needed

Group Type: EXPERIMENTAL

Hydroxyzine Hydrochloride

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Pamela Berens

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Berens, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Central Contacts

Pamela Berens, MD

Role: CONTACT

Pamela.D.Berens@uth.tmc.edu

(713) 500-6471

Sunbola A Ademola

Role: CONTACT

Sunbola.S.Ashimi@uth.tmc.edu

(713) 500-6410

Facility Contacts

Pamela Berens, MD

Role: primary

Pamela.D.Berens@uth.tmc.edu

713-500-6471

Sunbola A Ademola

Role: backup

Sunbola.S.Ashimi@uth.tmc.edu

(713) 500-6410

Other Identifiers

HSC-MS-25-0136

Identifier Type: -

Identifier Source: org_study_id