Pilot Study: A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum

Conditions
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Pelvic Exam

Intervention / Treatment
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* Device: Bouquet speculum
* Device: Traditional plastic 2-blade disposable speculum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients that require a pelvic exam. 18 years of age or older Having had at least one previous pelvic exam with the traditional speculum Consent to participate in the study Exclusion Criteria: - Never had a pelvic exam before

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This randomized single-blinded clinical study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional plastic 2-blade disposable speculum<br>Patients assigned to this arm will be evaluated using the traditional plastic 2-blade disposable speculum | Device: Traditional plastic 2-blade disposable speculum<br>* Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient<br>|
| Experimental: 5-petal Bouquet speculum<br>Patients assigned to this arm will be evaluated using the 5-petal Bouquet speculum | Device: Bouquet speculum<br>* Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient<br>* Other names: 884.4520;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: What was the level of comfort with this Pap smear compared to other speculum exams you have had? (More comfortable, Same level of comfort/discomfort, Less comfortable ) Based on what you anticipated the exam was: (More comfortable, As comfortable/uncomfortable, Less comfortable) On a scale from 0 to 10, what is the highest level of pain you experienced during the Pap smear/speculum exam? (10 being the worst pain you have ever experienced, and 0 being no pain) Did the doctor who performed the exam ask you adjust your body position while the speculum was inserted? (Yes, No) What is your estimation of how long the speculum was inserted? (0-30 seconds, 30-60 seconds, 1-2 minutes, 2-3 minutes, >3 minutes) | 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: During the speculum exam, were the lateral walls of the cervix easily visualized upon initial visualization of the cervix? (Yes, No) What is your estimate of how long the speculum was inserted? (0-30 seconds, 30-60 seconds, 1-2 minutes, 2-3 minutes, >3 minutes) While the speculum was inserted, was the patient asked to adjust body position in order to gain a better view of the cervix? (Yes, No) Were special maneuvers performed in order to better visualize the cervix? (e.g. use a different size/type of speculum, apply a condom over the speculum to view the lateral walls, re-insert the speculum, etc.)? (Yes, No) | Immediately after the exam |