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This is a prospective cohort study to determine if using a birthing mirror during the patient's pelvic examination decreases patients's degree of vulnerability and discomfort.
In Obstetrics and Gynecology and its gynecologic subspecialties, the pelvic examination is routine practice for screening and diagnostic purposes. Nevertheless, due to their intimate nature, pelvic examinations may result in loss of control, embarrassment, discomfort and anxiety.
The mirror pelvic exam has been a proposed technique to decrease patient anxiety and improve comfort during an already uncomfortable examination. However, little research has focused on this modality to date.
The purpose of this study is to investigate whether the mirror pelvic exam decreases the level of vulnerability and discomfort experienced during the pelvic examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirror group | This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room. |
| |
| No mirror group | This group of patients decline a mirror, and they will undergo the standard pelvic examination. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usage of a mirror | Other | using a mirror during the pelvic examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability | VAS on vulnerability level will be measured after the pelvic exam, and group difference after controlling for baseline vulnerability, will be calculated. The VAS is a validated 100 millimeter scale with 'no vulnerability' represented as 0 mm and 'very vulnerable' equating to 100 mm. | 30 minutes after the pelvic exam |
| Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort | VAS on discomfort level will be measured after the pelvic exam, and group difference after controlling for baseline discomfort level, will be calculated. The VAS is a validated 100 millimeter scale with 'no pain' represented as 0 mm and 'most pain' equating to 100 mm. | 30 minutes after the pelvic exam |
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Inclusion Criteria:
Exclusion Criteria:
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All women 18 years of age to 80, who undergo pelvic exam by a physician at Cincinnati Urogynecology Associates, TriHealth will be approached for recruitment.
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Pauls, MD | TriHealth - Cincinnati Urogynecology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Urogynecology Associates | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33620906 | Derived | Tam T, Crisp CC, Hill AM, Aldrich E, Ghodsi V, Yook E, Yeung J, Pauls RN. Utilization of a Mirror During Pelvic Examinations: Does it Improve the Patient's Experience? Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):208-213. doi: 10.1097/SPV.0000000000000975. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirror Group | This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room. Usage of a mirror: using a mirror during the pelvic examination |
| FG001 | No Mirror Group | This group of patients decline a mirror, and they will undergo the standard pelvic examination. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirror Group | This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room. Usage of a mirror: using a mirror during the pelvic examination |
| BG001 | No Mirror Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability | VAS on vulnerability level will be measured after the pelvic exam, and group difference after controlling for baseline vulnerability, will be calculated. The VAS is a validated 100 millimeter scale with 'no vulnerability' represented as 0 mm and 'very vulnerable' equating to 100 mm. | There are 2 missing outcomes from Mirror group | Posted | Mean | Standard Error | mm | 30 minutes after the pelvic exam |
|
within 30 minutes after pelvic examination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirror Group | This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room. Usage of a mirror: using a mirror during the pelvic examination |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffanie Tam, Md | TriHealth Inc. | 513-463-4300 | Tiffanie_Tam@trihealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2019 | Feb 13, 2020 | Prot_SAP_000.pdf |
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This group of patients decline a mirror, and they will undergo the standard pelvic examination. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants checked all that apply | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This group of patients decline a mirror, and they will undergo the standard pelvic examination. |
|
|
|
| Primary | Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort | VAS on discomfort level will be measured after the pelvic exam, and group difference after controlling for baseline discomfort level, will be calculated. The VAS is a validated 100 millimeter scale with 'no pain' represented as 0 mm and 'most pain' equating to 100 mm. | Each group has 1 missing outcome. | Posted | Mean | Standard Error | mm | 30 minutes after the pelvic exam |
|
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | No Mirror Group | This group of patients decline a mirror, and they will undergo the standard pelvic examination. | 0 | 74 | 0 | 74 | 0 | 74 |
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