Papanicolaou SmearEASENCT00755599
Eisenhower's Alternative Speculum Examination
A study testing no-stirrup vaginal examination and Vaginal speculum examination done with stirrups. in people with Papanicolaou Smear, run by Eisenhower Army Medical Center at 1 site in United States.
Trial summary
This study will determine patient and provider preferences regarding vaginal speculum examinations done with and without stirrups. Primary research hypothesis: Women undergoing speculum examination will experience at least 20% less physical discomfort, 20% less sense of vulnerability, and 20% less sense of loss of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Papanicolaou Smear
- What is being tested?
- no-stirrup vaginal examination and Vaginal speculum examination done with stirrups.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2010
- 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
- Subjects must be 18 years of age or older and able to consent for themselves. All women undergoing speculum examinations for the following list of reasons will be eligible for this study. No other reasons for speculum examinations will be eligible. Eligible reasons:
- Pap smears during well woman examinations
- Pap smears during routine early pregnancy visit
- vaginal discharge
- vaginal bleeding
- sexually transmitted disease check
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eisenhower Army Medical Center
Fort Gordon, Georgia, 30509
About this study
Official title: The EASE Trial: Eisenhower's Alternative Speculum Examination
This study will determine patient and provider preferences regarding vaginal speculum examinations done with and without stirrups.
Primary research hypothesis: Women undergoing speculum examination will experience at least 20% less physical discomfort, 20% less sense of vulnerability, and 20% less sense of loss of control when using a no-stirrup method of examination compared to traditional in-stirrup examinations.
Secondary research hypothesis: 25% or less of the providers taught this alternative method of speculum examination will find it to be unacceptable.
Read the detailed description
Subjects will be consented for inclusion into the study at the time of their presentation for one of the eligible presenting complaints. Those that agree to be part of the study will then be randomized to either stirrup or no-stirrup examinations. This will be done by opening previously sealed envelops with a data collection sheet inside of it. The sheet will say "stirrups" or "no-stirrups" at the top. This choice will be made via a random number table prior to beginning the study. The patient will then undergo examination using the indicated procedure. See Appendix A.
All patients will undergo speculum examination with medium Graves speculum. Patients needing, or requesting, other size speculums will be removed from the study. The participating provider will fill out the top of the data collection sheets and the patient will be asked to fill out the bottom of the sheet after the provider leaves the room. The sheets will then be dropped off at the nurses' station or leave them in the examination room.
Multiple aspects of physical discomfort, sense of control and sense of vulnerability will be assessed using a continuous scale. Patients will be asked to place a mark on a continuous line between two extremes. The distance will then be measured in millimeters in order to convert it to a numeric value. The measurement will be done by an independent provider in a blinded manner.
Medical providers participating in the study will be consented for enrollment. They will be mailed consent forms and asked to sign them in front of a witness and mail the consent form back to the PI. They will be eligible as long as they believe they can enroll 25 patients over the course of approximately one year. Providers will be trained on how to perform a no-stirrup examination. The training will include standardized draping of patients as well as standardized positioning of patients in order to reduce the amount of variation introduced by the providers into these examinations. The training will include still images and an instructional video. The Principal Investigator will be available to anyone who has further questions regarding the technique. Participating providers will also be asked to perform at least 5 no-stirrup examinations on non-study subjects prior to beginning enrollment into the study to ensure familiarization with the technique. Providers will be recruited if they agree to attempt to enroll 25 or more patients to the study over the course of approximately one year. This will not be a difficult number to achieve for an active clinician.
Providers who had not been trained on the no-stirrup speculum examination prior to the beginning this study will be sent a questionnaire querying them about their experience with the method after all data is collected.
Protected Health Information will not be collect, so HIPAA forms will not be required.
- Conditions
- Papanicolaou Smear
- Being tested
- no-stirrup vaginal examination, Vaginal speculum examination done with stirrups.
- Keywords
- Papanicolaou Smear, Vaginitis, Patient Satisfaction
- Medical subject headings
- Vaginitis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no-stirrup vaginal examinationProcedure or surgery
Vaginal speculum examination done with feet on table extender.
Vaginal speculum examination done with stirrups.Procedure or surgery
Speculum examination done with feet in stirrups.
| Study group | Role | What they receive |
|---|---|---|
| No Stirrups | Active comparator | Vaginal speculum examinations done without stirrups. The woman's feet will be placed onto the exam table allowing maximal repositioning by the woman. Receives: Procedure: no-stirrup vaginal examination |
| Stirrups | Active comparator | Speculum examination with feet in stirrups. The woman's feet will be placed into obstetric stirrups which fix the feet in place. Receives: Procedure: Vaginal speculum examination done with stirrups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical discomfort
As measured by a visual analog scale immediately after the procedure.
Measured: Immediately post-procedure
Secondary outcomes (2)
sense of loss of control
As measured by a visual analog scale immediately after the procedure.
Measured: Immediately post-procedure
sense of vulnerability
As measured by a visual analog scale immediately after the procedure.
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: recruiting issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papanicolaou SmearStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization into one of two arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisenhower Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Pearl Network
- Responsible party
- Sponsor
- Investigators
- Dean A Seehusen, MD, MPH, Principal investigator, Eisenhower Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755599
- Sponsor's protocol ID
- DDEAMC 07-15
- Acronym
- EASE
- Status last verified
- Aug 2024
- First submitted
- 17 Sep 2008
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EASE Trial: Eisenhower's Alternative Speculum Examination
- ClinicalTrials.gov ID
- NCT00755599
- Acronym / sponsor ID
- EASE / DDEAMC 07-15
- Conditions
- Papanicolaou Smear
- Keywords
- Papanicolaou Smear, Vaginitis, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruiting issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eisenhower Army Medical CenterUS federal agency
- Collaborators
- Pearl Network
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Sep 2008 (estimated)
- 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.
This study will determine patient and provider preferences regarding vaginal speculum examinations done with and without stirrups.
Primary research hypothesis: Women undergoing speculum examination will experience at least 20% less physical discomfort, 20% less sense of vulnerability, and 20% less sense of loss of control when using a no-stirrup method of examination compared to traditional in-stirrup examinations.
Secondary research hypothesis: 25% or less of the providers taught this alternative method of speculum examination will find it to be unacceptable.
Detailed description
Subjects will be consented for inclusion into the study at the time of their presentation for one of the eligible presenting complaints. Those that agree to be part of the study will then be randomized to either stirrup or no-stirrup examinations. This will be done by opening previously sealed envelops with a data collection sheet inside of it. The sheet will say "stirrups" or "no-stirrups" at the top. This choice will be made via a random number table prior to beginning the study. The patient will then undergo examination using the indicated procedure. See Appendix A.
All patients will undergo speculum examination with medium Graves speculum. Patients needing, or requesting, other size speculums will be removed from the study. The participating provider will fill out the top of the data collection sheets and the patient will be asked to fill out the bottom of the sheet after the provider leaves the room. The sheets will then be dropped off at the nurses' station or leave them in the examination room.
Multiple aspects of physical discomfort, sense of control and sense of vulnerability will be assessed using a continuous scale. Patients will be asked to place a mark on a continuous line between two extremes. The distance will then be measured in millimeters in order to convert it to a numeric value. The measurement will be done by an independent provider in a blinded manner.
Medical providers participating in the study will be consented for enrollment. They will be mailed consent forms and asked to sign them in front of a witness and mail the consent form back to the PI. They will be eligible as long as they believe they can enroll 25 patients over the course of approximately one year. Providers will be trained on how to perform a no-stirrup examination. The training will include standardized draping of patients as well as standardized positioning of patients in order to reduce the amount of variation introduced by the providers into these examinations. The training will include still images and an instructional video. The Principal Investigator will be available to anyone who has further questions regarding the technique. Participating providers will also be asked to perform at least 5 no-stirrup examinations on non-study subjects prior to beginning enrollment into the study to ensure familiarization with the technique. Providers will be recruited if they agree to attempt to enroll 25 or more patients to the study over the course of approximately one year. This will not be a difficult number to achieve for an active clinician.
Providers who had not been trained on the no-stirrup speculum examination prior to the beginning this study will be sent a questionnaire querying them about their experience with the method after all data is collected.
Protected Health Information will not be collect, so HIPAA forms will not be required.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization into one of two arms
| Arm | Type | Receives |
|---|---|---|
| No Stirrups | Active comparator | Procedure: no-stirrup vaginal examinationVaginal speculum examinations done without stirrups. The woman's feet will be placed onto the exam table allowing maximal repositioning by the woman. |
| Stirrups | Active comparator | Procedure: Vaginal speculum examination done with stirrups.Speculum examination with feet in stirrups. The woman's feet will be placed into obstetric stirrups which fix the feet in place. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be 18 years of age or older and able to consent for themselves. All women undergoing speculum examinations for the following list of reasons will be eligible for this study. No other reasons for speculum examinations will be eligible. Eligible reasons:
- Pap smears during well woman examinations
- Pap smears during routine early pregnancy visit
- vaginal discharge
- vaginal bleeding
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| no-stirrup vaginal examinationVaginal speculum examination done with feet on table extender. | Procedure or surgery | No Stirrups |
| Vaginal speculum examination done with stirrups.Speculum examination done with feet in stirrups. | Procedure or surgery | Stirrups |
Primary outcome
physical discomfort
Time frame: Immediately post-procedure
As measured by a visual analog scale immediately after the procedure.
2 secondary outcomes
sense of loss of control
Time frame: Immediately post-procedure
sense of vulnerability
Time frame: Immediately post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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.
Dean A Seehusen, MD, MPH principal investigator
Eisenhower Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no-stirrup vaginal examination and Vaginal speculum examination done with stirrups. in people with Papanicolaou Smear, run by Eisenhower Army Medical Center 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 6 inclusion and 0 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: withdrawn, as of the sponsor's last update on 28 Aug 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
physical discomfort (time frame: Immediately 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 28 Aug 2024.