Patient ComfortGYNNCT01788124
A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort
An observational study of Patient Comfort, run by St. John Health System, Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the comfort of two type of speculums used during routine gynecologic exam. Your treatment and medical care will not change because you are participating in this study. Your doctor will continue to make all decisions regarding your proper treatment and care. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Comfort
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2012
- Phase
- Observational
- 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 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women greater than 18 years of age presenting for routine speculum exam
Who may be able to join
- Any woman presenting to Great Lakes Obstetrics and Gynecology or Macomb Academic OB/GYN Clinic for a routine gynecological exam
- Women ≥ 18 years of age
- Women willing and able to give informed consent according to the guidelines established by the St John IRB
Who cannot join
- Patients that can not or will not sign the informed consent document
- Women whose English language skills are insufficient to understand the written informed consent or the post examination questionnaire.
- Any woman for who use of a speculum is contraindicated.
- Any woman with a condition that might alter pain perception
- Current pain medication use
- History of drug abuse
Show all 15Show fewer
- History of painful speculum examination
- Menopausal women
- Women who are pregnant or within 6 weeks of delivery
- Women presenting with dyspareunia, vaginitis, vulvar pain or vulvar lesions
- Women presenting for a vulvar, vaginal or uterine procedure.
- Women who have had a previous abnormal PAP smear (Cervical Intraepithelial Neoplasia >1)
- Women ≤ 18 years of age.
- Women who have never had vaginal intercourse.
- Women who have never had a speculum examination in the past
Trial locations and contacts
1 site in 1 country.
United States1 site
St John Macomb Oakland Hospital
Warren, Michigan, 48093
About this study
Official title: A Randomized Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort
The purpose of this study is to evaluate the comfort of two type of speculums used during routine gynecologic exam. Your treatment and medical care will not change because you are participating in this study. Your doctor will continue to make all decisions regarding your proper treatment and care.
Read the detailed description
Speculum examination is a common procedure in the gynecology clinic used for evaluation of numerous conditions such as vaginitis, and during cervical cytology screening (PAP smears). The speculum is inserted into the woman's vagina and used to keep the vaginal walls apart during exam and procedures. Each step of the examination with a speculum including insertion, manipulation during examination, and removal can cause discomfort for the patient. Fear of examination pain is considered one barrier to examination compliance. Any method to decrease discomfort during the exam would be considered beneficial to patient screening.
Typically two types of speculums are used in clinical practice, metal and plastic. There are advantages to both, and usage is usually predicated by physician preference. Previous studies have demonstrated a clear difference in patient comfort between metal speculums and newer dilating speculums such as the Vera scope (1). Clinical trials have also shown the benefit of using lubrication on metal speculums during routine exams (2). To date there are no clinical trails to examine the difference in patient comfort between metal and plastic bi-valve speculums.
- Conditions
- Patient Comfort
- Keywords
- Speculum, Metal, Plastic, Visual Analoge Scale, Discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metal Speculum | exam with metal speculum | |
| Plastic Speculum | exam with plastic speculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Discomfort VAS
. Patients presenting for routine gynecological examination will be randomized to either plastic or metal speculum arm. Patient discomfort will be assessed using a self administered visual analogue scale (VAS). Patient comfort between groups will be assessed
Measured: up to one day post exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComfortStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John Health System, Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Shaw PhD, St. John Health System, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788124
- Sponsor's protocol ID
- macomb0001
- Acronym
- GYN
- Status last verified
- Feb 2013
- First submitted
- 4 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort
- ClinicalTrials.gov ID
- NCT01788124
- Acronym / sponsor ID
- GYN / macomb0001
- Conditions
- Patient Comfort
- Keywords
- Speculum, Metal, Plastic, Visual Analoge Scale, Discomfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- St. John Health System, MichiganUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Feb 2013 (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.
The purpose of this study is to evaluate the comfort of two type of speculums used during routine gynecologic exam. Your treatment and medical care will not change because you are participating in this study. Your doctor will continue to make all decisions regarding your proper treatment and care.
Detailed description
Speculum examination is a common procedure in the gynecology clinic used for evaluation of numerous conditions such as vaginitis, and during cervical cytology screening (PAP smears). The speculum is inserted into the woman's vagina and used to keep the vaginal walls apart during exam and procedures. Each step of the examination with a speculum including insertion, manipulation during examination, and removal can cause discomfort for the patient. Fear of examination pain is considered one barrier to examination compliance. Any method to decrease discomfort during the exam would be considered beneficial to patient screening.
Typically two types of speculums are used in clinical practice, metal and plastic. There are advantages to both, and usage is usually predicated by physician preference. Previous studies have demonstrated a clear difference in patient comfort between metal speculums and newer dilating speculums such as the Vera scope (1). Clinical trials have also shown the benefit of using lubrication on metal speculums during routine exams (2). To date there are no clinical trails to examine the difference in patient comfort between metal and plastic bi-valve speculums.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal Speculum | – | –exam with metal speculum |
| Plastic Speculum | – | –exam with plastic speculum |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women greater than 18 years of age presenting for routine speculum exam
Key inclusion criteria (3 listed)
- Any woman presenting to Great Lakes Obstetrics and Gynecology or Macomb Academic OB/GYN Clinic for a routine gynecological exam
- Women ≥ 18 years of age
- Women willing and able to give informed consent according to the guidelines established by the St John IRB
Key exclusion criteria (15 listed)
- Patients that can not or will not sign the informed consent document
- Women whose English language skills are insufficient to understand the written informed consent or the post examination questionnaire.
- Any woman for who use of a speculum is contraindicated.
- Any woman with a condition that might alter pain perception
- Current pain medication use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Discomfort VAS
Time frame: up to one day post exam
. Patients presenting for routine gynecological examination will be randomized to either plastic or metal speculum arm. Patient discomfort will be assessed using a self administered visual analogue scale (VAS). Patient comfort between groups will be assessed
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 11 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patient Comfort, run by St. John Health System, Michigan 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 3 inclusion and 15 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 11 Feb 2013. 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?
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?
Patient Discomfort VAS (time frame: up to one day post exam). 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 11 Feb 2013.