Anxiety, Pain
Conditions
Keywords
intrauterine device (IUD) insertion, endometrial biopsy (EMB)
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.
Interventions
DRUGParacervical 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.
DRUGBenzocaine 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.
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactPamela Berens, MD
Backup ContactSunbola A Ademola
Outcome results
None listed