Pain Management Optimization for In-Office Gynecologic Procedures: The Development and Evaluation of a Risk-Stratification Pain Calculator
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Average Perceived Pain Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Average Perceived Pain Score
Time Frame: 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
Time Frame: 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 Outcomes
- Average Perceived Pain Stratified by Risk Group(At time of procedure and at 10 minutes after procedure)
- Participant Satisfaction with Procedure Stratified by Risk Group(at time of procedure)
Investigators
Claire Aucoin
Co-Investigator
Carle Foundation Hospital