Gynecologic Procedures, Pain Management, Patient Satisfaction
Conditions
Keywords
pain management, patient satisfaction, gynecologic procedures, IUD insertion, hysteroscopy, endometrial biopsy, colposcopy, ambulatory gynecologic procedures
Brief summary
The goal of this clinical trial is to learn how using a risk-stratification calculator to determine the risk of a patient experiencing severe pain during an in-office gynecologic procedure and subsequently assigning pain medications to be used for the procedure based on risk, will affect patients' pain during these procedures. The main questions it aims to answer are: * Does using pain medications determined by a risk-stratification calculator improve patients' pain scores during if-office gynecologic procedures? * Does using pain medications determined by a risk-stratification calculator improve patient satisfaction? Researchers will compare using the risk-stratification calculator to decide on pain medications to a provider using their best judgement to decide on pain medications. This will help determine if patients have improved pain scores and satisfaction if they have their pain medications assigned using the risk-stratification calculator. Participants who are undergoing a relevant in-office gynecologic procedure will: * Receive pain medications for their procedure either based on their answers to questions for the risk-stratification calculator or based on their provider's best judgement. * Answer an online survey about their experience with the procedure and related pain management.
Interventions
OTHERPain Calculator
The risk-stratification calculator, or the Pain Calculator, will be a questionnaire that the participant will answer with a research team member. The questions asked will include age, menopausal status, delivery history, history of certain gynecologic disorders, past experiences with gynecologic procedures, and anxiety about their upcoming procedure. Their answers will sort participants into low, moderate, and high risk groups. Each group will receive escalating pain medications for their procedure.
Sponsors
Carle Foundation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Proficient in English * Access to personal smart devices (smartphone, tablet, laptop, etc.) * Will be undergoing the following in-office gynecologic procedures: IUD insertion, endometrial biopsy, colposcopy with cervical biopsy, or hysteroscopy
Exclusion criteria
* Under the age of 18 * Non-English-Speaking * Have contraindications to taking NSAIDs, acetaminophen, lidocaine or its derivatives, or opioids * Patients who are taking methadone, Suboxone, and/or naltrexone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Perceived Pain Score | At time of procedure and at 10 minutes after procedure | Participants will rank their pain perceived during their procedures from 0, equivalent to no pain, to 10, equivalent to worst imaginable pain. |
| Participant Satisfaction with Procedure | At time of procedure | Participants will rank their satisfaction with their experience during the procedure using a standard Likert Scale, ranging from 1, not at all satisfied, to 5, highly satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Perceived Pain Stratified by Risk Group | At time of procedure and at 10 minutes after procedure | Using the same pain scale - 0 (no pain at all) to 10 (worst imaginable pain), pain scores of experimental group participants stratified by Risk Group will be each compared to the control group. |
| Participant Satisfaction with Procedure Stratified by Risk Group | at time of procedure | Using the same Likert Scale - 1 (not at all satisfied) to 5 (highly satisfied), experimental group participants stratified by Risk Group will each be compared to the control group. |
Countries
United States
Contacts
Primary ContactClaire M Aucoin, MD
Backup ContactBeverly London, MD
Outcome results
None listed