Investigating Pre-Procedural Anxiety and Effect of Analgesia on Intrauterine Device Placement and Endometrial Biopsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paracervical block- Lidocaine without epinephrine, Benzocaine Gel applied to the cervix, Hydroxyzine Hydrochloride.
- Who it may be relevant to
- Registry conditions: Anxiety, Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- 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.]
Secondary outcome measures (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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT07031206 · HSC-MS-25-0136