Pain ManagementNCT07311824
Pain Management for In-Office Gynecologic Procedures Using a Risk-Stratification Pain Calculator
A study testing Pain Calculator in people with Pain Management and Patient Satisfaction, run by Carle Foundation Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain Management, Patient Satisfaction, Gynecologic Procedures
- What is being tested?
- Pain Calculator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Dec 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Carle Champaign on Curtis
Champaign, Illinois, 61822
Beverly M London, MD, 217-365-6208, beverly.london@carle.com
Claire M Aucoin, MD, 217-383-3140 ext. 3, claire.aucoin@carle.com
Carle Foundation Hospital
Urbana, Illinois, 61801
Claire M Aucoin, MD, 217-383-3140 ext. 3, claire.aucoin@carle.com
Beverly London, MD, beverly.london@carle.com
About this study
Official title: Pain Management Optimization for In-Office Gynecologic Procedures: The Development and Evaluation of a Risk-Stratification Pain Calculator
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?
Read more
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.
- Being tested
- Pain Calculator
- Keywords
- pain management, patient satisfaction, gynecologic procedures, IUD insertion, hysteroscopy, endometrial biopsy, colposcopy, ambulatory gynecologic procedures
- Medical subject headings
- Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain CalculatorOther
Also called risk-stratification calculator, risk-stratification algorithm
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain Calculator | Experimental | Participants will answer the Pain Calculator Questionnaire that will determine if they are low, moderate, or high risk for severe pain during their procedure. They will receive assigned pain medications based on their risk. Receives: Other: Pain Calculator |
| Control | No intervention | Participants will have their pain management determined by the provider's best judgement, using shared decision making |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of procedure and at 10 minutes after procedure
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.
Measured: At time of procedure
Secondary outcomes (2)
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.
Measured: At time of procedure and at 10 minutes after procedure
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.
Measured: at time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start29 Dec 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carle Foundation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Aucoin, Carle Foundation Hospital
- Investigators
- Beverly London, MD, Principal investigator, Carle Foundation HospitalGeorgina Cheng, MD PhD, Principal investigator, Carle Foundation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311824
- Sponsor's protocol ID
- 24CRU4052
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management Optimization for In-Office Gynecologic Procedures: The Development and Evaluation of a Risk-Stratification Pain Calculator
- ClinicalTrials.gov ID
- NCT07311824
- Acronym / sponsor ID
- 24CRU4052
- Keywords
- pain management, patient satisfaction, gynecologic procedures, IUD insertion, hysteroscopy, endometrial biopsy, colposcopy, ambulatory gynecologic procedures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carle Foundation HospitalUniversity, hospital or other
- Study start
- 29 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Calculator | Experimental | Other: Pain CalculatorParticipants will answer the Pain Calculator Questionnaire that will determine if they are low, moderate, or high risk for severe pain during their procedure. They will receive assigned pain medications based on their risk. |
| Control | No intervention | –Participants will have their pain management determined by the provider's best judgement, using shared decision making |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain CalculatorAlso: risk-stratification calculator, risk-stratification algorithmThe 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. | Other | Pain Calculator |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beverly London, MD principal investigator
Carle Foundation Hospital
Georgina Cheng, MD PhD principal investigator
Carle Foundation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Calculator in people with Pain Management and Patient Satisfaction, run by Carle Foundation Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire M Aucoin, MD (217-383-3140 ext. 3, claire.aucoin@carle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Perceived Pain Score (time frame: At time of procedure and at 10 minutes after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.