A Randomized Controlled Trial of Gynecological Speculum Examination: Straight Horizontal Insertion vs. Vertical Insertion and Rotation
Sponsor study identifier
interventional
41
1 country
1
Study Start
November 27, 2015
Actual (reported)Primary Completion
November 27, 2021
Actual (reported)Study Completion
November 27, 2021
Actual (reported)This study compares two different types of speculum insertion to determine the level of discomfort they might cause. This study compares the straight horizontal insertion (SHI) of the speculum and the vertical insertion and rotation (VIR). Participants are randomly assigned to one of the two insertion groups and are not told which group they are in until the examination is over. Participants rate their level of discomfort immediately after insertion of the speculum. Basic demographic information (e.g., age, ethnicity, number of vaginal deliveries, menopausal status, etc.) and clinical information are also collected to determine if other factors influence the level of discomfort experienced. \*NOTE\* This is NOT a paid study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 27, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2015
Actual (reported)March 2, 2016
Actual (reported)March 15, 2016
Actual (reported)November 27, 2021
Actual (reported)November 27, 2021
Actual (reported)Pain/discomfort ratings of women receiving straight horizontal speculum insertion vs. those receiving vertical speculum insertion and rotation, as measured by a visual analog scale
The primary objective of this study is to quantify the amount of pain/discomfort women experience with two different types of speculum insertion: straight horizontal insertion (SHI) and vertical insertion and rotation (VIR). Participants will rate their pain/discomfort by placing a mark on a visual analog scale measuring 10 cm in length. Pain/discomfort ratings on this scale range from "no pain" to "pain as bad as it possibly could be".
Measured immediately after speculum insertion
Vertical insertion and 90 degree rotation of speculum in vagina
Straight horizontal insertion of speculum with no rotation in vagina
Speculum insertion type will either be vertical rotation (as per common practice in Canada) or straight horizontal insertion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mark Yudin, MD
Unity Health Toronto
41 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2016
First Posted
March 15, 2016
Study Start
November 27, 2015
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 27, 2021
Actual (reported)Study Completion
November 27, 2021
Actual (reported)Last Updated
December 18, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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