Vaginal Speculum ExaminationNCT02708615
Gynaecological Speculum Examination: Straight Horizontal Insertion Versus Vertical Insertion and Rotation.
A study testing Type of speculum vaginal insertion method in people with Vaginal Speculum Examination, run by Unity Health Toronto at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Speculum Examination
- What is being tested?
- Type of speculum vaginal insertion method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2015to 27 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are 18 years of age or older
- Undergoing a speculum examination as part of their regular clinical care
- Proficient knowledge of the English language and able to sign the informed consent form
Who cannot join
- Younger than 18 years of age
- Women with a history of vulvodynia, vaginismus, or dyspareunia
- No prior sexual activity or intercourse
- Active vaginal, cervical, uterine or adnexal infection
- Active pregnancy or within 6 weeks postpartum
- Vulvar or vaginal surgery within three months
- Psychiatric conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Gynecological Speculum Examination: Straight Horizontal Insertion vs. Vertical Insertion and Rotation
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Vaginal Speculum Examination
- Being tested
- Type of speculum vaginal insertion method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of speculum vaginal insertion methodOther
Speculum insertion type will either be vertical rotation (as per common practice in Canada) or straight horizontal insertion
| Study group | Role | What they receive |
|---|---|---|
| Vertical rotation | Other | Vertical insertion and 90 degree rotation of speculum in vagina Receives: Other: Type of speculum vaginal insertion method |
| Straight horizontal insertion | Other | Straight horizontal insertion of speculum with no rotation in vagina Receives: Other: Type of speculum vaginal insertion method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured immediately after speculum insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start27 Nov 2015
- Primary completion27 Nov 2021
- Study completion27 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Speculum ExaminationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Yudin, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708615
- Sponsor's protocol ID
- 15-082
- Status last verified
- Dec 2023
- First submitted
- 2 Mar 2016
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Gynecological Speculum Examination: Straight Horizontal Insertion vs. Vertical Insertion and Rotation
- ClinicalTrials.gov ID
- NCT02708615
- Acronym / sponsor ID
- 15-082
- Conditions
- Vaginal Speculum Examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 27 Nov 2015 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 27 Nov 2021 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertical rotation | Other | Other: Type of speculum vaginal insertion methodVertical insertion and 90 degree rotation of speculum in vagina |
| Straight horizontal insertion | Other | Other: Type of speculum vaginal insertion methodStraight horizontal insertion of speculum with no rotation in vagina |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who are 18 years of age or older
- Undergoing a speculum examination as part of their regular clinical care
- Proficient knowledge of the English language and able to sign the informed consent form
Key exclusion criteria (7 listed)
- Younger than 18 years of age
- Women with a history of vulvodynia, vaginismus, or dyspareunia
- No prior sexual activity or intercourse
- Active vaginal, cervical, uterine or adnexal infection
- Active pregnancy or within 6 weeks postpartum
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 |
|---|---|---|
| Type of speculum vaginal insertion methodSpeculum insertion type will either be vertical rotation (as per common practice in Canada) or straight horizontal insertion | Other | Straight horizontal insertion, Vertical rotation |
Primary outcome
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
Time frame: Measured immediately after speculum insertion
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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.
Mark Yudin, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of speculum vaginal insertion method in people with Vaginal Speculum Examination, run by Unity Health Toronto at 1 site in Canada.
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 3 inclusion and 7 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 18 Dec 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: Measured immediately after speculum insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2023.