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Not yet recruiting NCT07311824

Pain Management for In-Office Gynecologic Procedures Using a Risk-Stratification Pain Calculator

No phase Interventional Pain Management Patient Satisfaction Gynecologic Procedures

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: Pain Calculator.
Who it may be relevant to
Registry conditions: Pain Management, Patient Satisfaction, Gynecologic Procedures. 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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Official title

Pain Management Optimization for In-Office Gynecologic Procedures: The Development and Evaluation of a Risk-Stratification Pain Calculator

Overview

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

  • Other Pain 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 proced

Primary outcome measures

  • Average Perceived Pain Score [Time frame: At time of procedure and at 10 minutes after procedure]
  • Participant Satisfaction with Procedure [Time frame: At time of procedure]
Secondary outcome measures (2)
  • Average Perceived Pain Stratified by Risk Group [Time frame: At time of procedure and at 10 minutes after procedure]
  • Participant Satisfaction with Procedure Stratified by Risk Group [Time frame: at time of procedure]

Eligibility criteria

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

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
Treatment

Study locations

United States · 2 centers
  • Carle Champaign on Curtis — Champaign
  • Carle Foundation Hospital — Urbana

Identifiers

NCT: NCT07311824 · 24CRU4052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗