An interventional study of Type of speculum vaginal insertion method in Vaginal Speculum Examination, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Other
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.
In most medical schools around the world, speculum examination is taught using a bivalved speculum, since this is the type of speculum most commonly used in clinical practice. Due to the oval shape of the vulva, and the alignment of the labia majora and minora, the aperture of vaginal introitus is commonly perceived to have a vertical orientation. In reality however, the vaginal introitus is round and the vagina itself has more of a horizontal orientation: the anterior and posterior vaginal walls are opposed, and the sidewalls only become apparent once the anterior and posterior walls are separated. Nevertheless, the most common way of teaching the speculum examination worldwide is to introduce the speculum in a vertical orientation and then once it is successfully inserted into the vagina to rotate it 90° into a horizontal position. Once it is correctly positioned, it is slowly opened to visualize the vaginal epithelium and the cervix. However, in clinical practice, the rotation of the speculum in the vagina may cause pain and discomfort. Introduction of the speculum initially in a horizontal orientation, without rotation in the vagina, seems more appropriate and could potentially be associated with less discomfort or pain for women undergoing this exam. In practice, a minority of clinicians separate the labia first, introduce the speculum in a direct horizontal fashion, and thus avoid the potentially uncomfortable twisting part of the procedure.
Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vertical insertion and 90 degree rotation of speculum in vagina
Other: Type of speculum vaginal insertion method
Straight horizontal insertion of speculum with no rotation in vagina
Other: Type of speculum vaginal insertion method
Speculum insertion type will either be vertical rotation (as per common practice in Canada) or straight horizontal insertion
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".
Time frame: Measured immediately after speculum insertion
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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