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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

May 5, 2026

Study Completion Date

May 5, 2026

Conditions
AnxietyPain
Interventions
DRUG

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.

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.

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.

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER