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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07031206
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
May 5, 2026
Completion
May 5, 2026

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed
  • Experimental: Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed
  • Experimental: No analgesia with Hydroxyzine hydrochloride if needed

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Pamela Berens, MD
[email protected]
713-500-6471
Sunbola A Ademola
[email protected]
(713) 500-6410

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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