Utilization of the Mirror During Pelvic Exams

NCT ID: NCT03785548

Last Updated: 2020-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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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

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Pelvic Exam

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type OTHER

using a mirror during the pelvic examination

No mirror group

This group of patients decline a mirror, and they will undergo the standard pelvic examination.

No interventions assigned to this group

Interventions

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Usage of a mirror

using a mirror during the pelvic examination

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Pauls, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth - Cincinnati Urogynecology Associates

Locations

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Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33620906 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-107

Identifier Type: -

Identifier Source: org_study_id

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