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NCT Number: NCT07031206

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Pamela Berens, MD

CONTACT

[email protected]

(713) 500-6471

Sunbola A Ademola

CONTACT

[email protected]

(713) 500-6410

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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