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

Phase 2

Not yet recruiting

• Conditions: Anxiety; Pain
• Interventions: Drug: Paracervical block- Lidocaine without epinephrine; Drug: Benzocaine Gel applied to the cervix; Drug: Hydroxyzine Hydrochloride

• Registration Number: NCT07031206
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Study Start: 2025-07-01
• Primary Completion: 2026-05-05
• Study Completion: 2026-05-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed	Paracervical block- Lidocaine without epinephrine	-
Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed	Hydroxyzine Hydrochloride	-
Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed	Benzocaine Gel applied to the cervix	-
Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed	Hydroxyzine Hydrochloride	-
No analgesia with Hydroxyzine hydrochloride if needed	Hydroxyzine Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Change in pain perception during IUD insertion as assessed by the Faces Pain Visual Analogue Scale (VAS)	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States