Pelvic ExamNCT03785548
Utilization of the Mirror During Pelvic Exams
An observational study of Pelvic Exam, run by TriHealth Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Exam
- What is being tested?
- Usage of a mirror
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- New patients undergoing a pelvic exam performed by a physician at Cincinnati Urogynecology Associates, TriHealth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
About this study
Official title: Utilization of the Mirror During Pelvic Exams: Does it Reduce Patient Vulnerability and Discomfort?
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.
Read the 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.
- Conditions
- Pelvic Exam
- Being tested
- Usage of a mirror
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usage of a mirrorOther
using a mirror during the pelvic examination
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Usage of a mirror | |
| No mirror group | This group of patients decline a mirror, and they will undergo the standard pelvic examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes after the pelvic exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start15 Apr 2019
- Primary completion29 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic ExamStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Principal investigator, TriHealth - Cincinnati Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785548
- Sponsor's protocol ID
- 18-107
- Status last verified
- Jul 2020
- First submitted
- 19 Dec 2018
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33620906
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of the Mirror During Pelvic Exams: Does it Reduce Patient Vulnerability and Discomfort?
- ClinicalTrials.gov ID
- NCT03785548
- Acronym / sponsor ID
- 18-107
- Conditions
- Pelvic Exam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Posted 17 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror group | – | Other: Usage of a mirrorThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- New patients undergoing a pelvic exam performed by a physician at Cincinnati Urogynecology Associates, TriHealth
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usage of a mirrorusing a mirror during the pelvic examination | Other | Mirror group |
Primary outcome
Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33620906Tam 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.
- Individual participant dataSharing planned: No
Related trials for Pelvic Exam
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Pauls, MD principal investigator
TriHealth - Cincinnati Urogynecology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Exam, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability (time frame: 30 minutes after the pelvic exam). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.