Pain Management for In-Office Gynecologic Procedures Using a Risk-Stratification Pain Calculator
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCarle Foundation Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pain Calculator
Other interventionThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Pain CalculatorExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Average Perceived Pain Score
Participants will rank their pain perceived during their procedures from 0, equivalent to no pain, to 10, equivalent to worst imaginable pain.
Time frame
At time of procedure and at 10 minutes after procedure2
Participant Satisfaction with 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.
Time frame
At time of procedureSecondary outcomes
1
Average Perceived Pain Stratified by Risk Group
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.
Time frame
At time of procedure and at 10 minutes after procedure2
Participant Satisfaction with Procedure Stratified by Risk Group
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.
Time frame
at time of procedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: