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The study was stopped because of logistical issues with the sites.
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This randomized single-blinded clinical study will compare the typical 2-bladed plastic disposable vaginal speculum to the novel 5-petal Bouquet speculum on level of patient comfort, visibility of the cervix, and time length of the examination. The data will be collected via patient and provider questionnaires.
For nearly 200 years, the traditional 2-blade "Duck bill" vaginal speculum has had very little evolution in design. In past decades, there has been an increase in popularity in using the plastic speculum rather than the metal speculum. The plastic speculum has effectively the same design as the traditional metal vaginal speculum. The current 2-blade design that has been used for centuries leaves many women feeling pain or discomfort during a speculum vaginal exam. Furthermore, in obese and multiparous women, the 2-blade design often allows the lateral walls of the vagina to cave inward during the exam, preventing the provider from gaining full visibility of the cervix. Another common complaint is that the exam takes too long, which leaves patients in pain and feeling vulnerable for an extended period of time.
The novel 5-petal Bouquet vaginal speculum offers an alternative design that some have argued provides enhanced patient comfort, better visualization of the cervix, and is easier to use for the provider. This proposed study design is a blueprint that will be used to compare the Bouquet speculum to a traditional 2-blade disposable plastic speculum on patient comfort, visualization of the cervix, and ease of use for the provider. The investigators predict that the results of this study will help physicians and other medical providers provide patients with better experience, reducing or eliminating the current common complaints regarding how speculum exams are performed today.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional plastic 2-blade disposable speculum | Active Comparator | Patients assigned to this arm will be evaluated using the traditional plastic 2-blade disposable speculum |
|
| 5-petal Bouquet speculum | Experimental | Patients assigned to this arm will be evaluated using the 5-petal Bouquet speculum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bouquet speculum | Device | Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient comfort | Find the difference in the level of patient comfort during a vaginal speculum exam between the traditional 2-blade plastic disposable speculum and the 5-petal Bouquet speculum. Assessed with a questionnaire answered by the patient:
| Immediately after the exam |
| Length of time | Find the difference in the length of time that the Bouquet speculum is inserted during a Pap smear compared to the traditional 2-blade speculum. The time the speculum is inserted is recorded for every interactions. | During the exam |
| Ease of use | Find the difference in ease of use for the provider between the traditional 2-blade plastic disposable speculum and the 5-petal Bouquet speculum. Assessed with a questionnaire answered by the provider:
| Immediately after the exam |
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Inclusion Criteria:
Exclusion Criteria:
- Never had a pelvic exam before
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| Name | Affiliation | Role |
|---|---|---|
| James M Small, MD | Rocky Vista University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. George OB/GYN | St. George | Utah | 84790 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bouquet JM, Chernau A, McLaughlin R, Choudhury Q. 2019. A New Vaginal Speculum and an Inexpensive Kit to Screen and Treat Dysplasia and Cancer of the Cervix. Journal of Women's Health Care. 8.470 doi: 10.35248/2167-0420.19.8.470 |
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Unidentified data will be shared when reasonable request is asked to the principal investigator. however this is yet to be decided.
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This randomized single-blinded clinical study
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Patients who have an indication for a speculum exam and who meet other inclusion criteria will be randomized to either receive their exam with the traditional plastic 2-blade disposable speculum or the 5-petal Bouquet speculum. After the exam, the patient and the physician will each fill out a questionnaire that will ask about patient comfort, ease of use, visibility of the cervix, and perceived time of the exam.
| Traditional plastic 2-blade disposable speculum | Device | Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient |
|