Hysteroscopy SurgeryNCT05316506
Pain and Hysteroscopy
A study testing Anticipated Discomfort Language and Objective Descriptive Language in people with Hysteroscopy Surgery, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysteroscopy Surgery
- What is being tested?
- Anticipated Discomfort Language and Objective Descriptive Language
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults 18 years of age and older
- Scheduled for in office hysteroscopy
- Able to consent for the study in English or Spanish
Who cannot join
- Persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions)
- Previous in-office hysteroscopy
- Hysteroscopy for foreign body/ Intrauterine Device (IUD) removal
- Minors, prisoners, or other members of vulnerable populations
- Patients who cannot communicate in English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial
The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.
- Conditions
- Hysteroscopy Surgery
- Being tested
- Anticipated Discomfort Language, Objective Descriptive Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipated Discomfort LanguageOther
This language involves pain descriptors provided from physician to patient during procedure.
Objective Descriptive LanguageOther
This language involves neutral/objective descriptors provided from physician to patients during procedure.
| Study group | Role | What they receive |
|---|---|---|
| Anticipated Discomfort Group | Other | Participants will be prompted using anticipated discomfort language during the standard of care hysteroscopy. Receives: Other: Anticipated Discomfort Language |
| Objective Description Group | Other | Participants will be prompted using objective description language during the standard of care hysteroscopy. Receives: Other: Objective Descriptive Language |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain as measured by Visual Analog Scale (VAS)
Pain will be assessed using the Visual Analog Scale (VAS). Visual Analog Scale (VAS) is score from 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline (pre-procedure), Day 1 (post-procedure)
Secondary outcomes (1)
Number of participants in each pain category
Number of participants reporting actual pain compared to their anticipated the pain post procedure.
- Pain Free
- Less painful than anticipated
- As painful as anticipated
- More painful than anticipated
- Much more painful than anticipated
Measured: Day 1 (post-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysteroscopy SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carugno, University of Miami
- Investigators
- Jose Carugno, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316506
- Sponsor's protocol ID
- 20211092
- Status last verified
- Sep 2023
- First submitted
- 30 Mar 2022
- Last updated
- 26 Sep 2023
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05316506
- Acronym / sponsor ID
- 20211092
- Conditions
- Hysteroscopy Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Apr 2022 (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 purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticipated Discomfort Group | Other | Other: Anticipated Discomfort LanguageParticipants will be prompted using anticipated discomfort language during the standard of care hysteroscopy. |
| Objective Description Group | Other | Other: Objective Descriptive LanguageParticipants will be prompted using objective description language during the standard of care hysteroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years of age and older
- Scheduled for in office hysteroscopy
- Able to consent for the study in English or Spanish
Key exclusion criteria (5 listed)
- Persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions)
- Previous in-office hysteroscopy
- Hysteroscopy for foreign body/ Intrauterine Device (IUD) removal
- Minors, prisoners, or other members of vulnerable populations
- Patients who cannot communicate in English or Spanish
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 |
|---|---|---|
| Anticipated Discomfort LanguageThis language involves pain descriptors provided from physician to patient during procedure. | Other | Anticipated Discomfort Group |
| Objective Descriptive LanguageThis language involves neutral/objective descriptors provided from physician to patients during procedure. | Other | Objective Description Group |
Primary outcome
Change in Pain as measured by Visual Analog Scale (VAS)
Time frame: Baseline (pre-procedure), Day 1 (post-procedure)
Pain will be assessed using the Visual Analog Scale (VAS). Visual Analog Scale (VAS) is score from 0 (no pain) to 10 (worst pain imaginable).
1 secondary outcome
Number of participants in each pain category
Time frame: Day 1 (post-procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- 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. This study is not recruiting at the moment.
Jose Carugno, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipated Discomfort Language and Objective Descriptive Language in people with Hysteroscopy Surgery, run by University of Miami at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain as measured by Visual Analog Scale (VAS) (time frame: Baseline (pre-procedure), Day 1 (post-procedure)). 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 26 Sep 2023.