Pelvic Exam
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERUsage of a mirror
using a mirror during the pelvic examination
Sponsors
TriHealth Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* New patients undergoing a pelvic exam performed by a physician at Cincinnati Urogynecology Associates, TriHealth
Exclusion criteria
* Existing patients * Unwillingness to participate in the study * Physical or mental impairment that would affect the subject's ability to visualize the mirror during examination or to complete questionnaires * Inability to understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability | 30 minutes after the pelvic exam | 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. |
| Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort | 30 minutes after the pelvic exam | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 71 |
| No Mirror Group This group of patients decline a mirror, and they will undergo the standard pelvic examination. | 74 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | age > 80 | 1 | 0 |
| Overall Study | no Postop queries | 1 | 0 |
Baseline characteristics
| Characteristic | Mirror Group | No Mirror Group | Total |
|---|---|---|---|
| Age, Continuous | 53.99 years STANDARD_DEVIATION 12.96 | 57.84 years STANDARD_DEVIATION 13.86 | 55.95 years STANDARD_DEVIATION 13.52 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 5 Participants | 15 Participants |
| Race/Ethnicity, Customized missing | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 62 Participants | 66 Participants | 128 Participants |
| Region of Enrollment United States | 71 participants | 74 participants | 145 participants |
| Sex: Female, Male Female | 71 Participants | 74 Participants | 145 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 74 |
| other Total, other adverse events | 0 / 71 | 0 / 74 |
| serious Total, serious adverse events | 0 / 71 | 0 / 74 |
Outcome results
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.
Time frame: 30 minutes after the pelvic exam
Population: Each group has 1 missing outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirror Group | Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort | 19.683 mm | Standard Error 2.201 |
| No Mirror Group | Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort | 19.824 mm | Standard Error 2.154 |
p-value: 0.96495% CI: [-5.983, 6.266]ANCOVA
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.
Time frame: 30 minutes after the pelvic exam
Population: There are 2 missing outcomes from Mirror group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirror Group | Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability | 13.294 mm | Standard Error 1.854 |
| No Mirror Group | Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability | 16.145 mm | Standard Error 1.789 |
p-value: 0.2795% CI: [-2.241, 7.944]ANCOVA