An observational study in Pelvic Exam, sponsored by TriHealth Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-17.
Sponsored by TriHealth Inc. · Observational
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.
TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Other: Usage of a mirror
This group of patients decline a mirror, and they will undergo the standard pelvic examination.
using a mirror during the pelvic examination
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
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
| Milestone | Mirror Group | No Mirror Group |
|---|---|---|
| Started | 73 | 74 |
| Completed | 71 | 74 |
| Not completed | 2 | 0 |
| Withdrew: Age > 80 | 1 | 0 |
| Withdrew: No postop queries | 1 | 0 |
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.
| mm | Mirror Group | No Mirror Group |
|---|---|---|
| Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability | 13.294 ± 1.854 | 16.145 ± 1.789 |
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.
| mm | Mirror Group | No Mirror Group |
|---|---|---|
| Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort | 19.683 ± 2.201 | 19.824 ± 2.154 |
Collected over within 30 minutes after pelvic examination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mirror Group | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| No Mirror Group | 0/74 (0%) | 0/74 (0%) | 0/74 (0%) |
| Age, Continuous(years) | Mirror Group | No Mirror Group | Total |
|---|---|---|---|
| Mean | 53.99 ± 12.96 | 57.84 ± 13.86 | 55.95 ± 13.52 |
| Sex: Female, Male(Participants) | Mirror Group | No Mirror Group | Total |
|---|---|---|---|
| Female | 71 | 74 | 145 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Mirror Group | No Mirror Group | Total |
|---|---|---|---|
| White | 62 | 66 | 128 |
| Black or African American | 10 | 5 | 15 |
| American Indian/Alaska Native | 2 | 0 | 2 |
| Asian | 1 | 0 | 1 |
| Prefer not to answer | 0 | 2 | 2 |
| missing | 0 | 1 | 1 |
| Region of Enrollment(participants) | Mirror Group | No Mirror Group | Total |
|---|---|---|---|
| United States | 71 | 74 | 145 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
TriHealth Inc.