Examination, GynecologicalNCT01289665
The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.
A study testing Lubricating gel used during speculum insertion. and Water used during speculum examination. in people with Examination, Gynecological and Examination, Pelvic, run by AdventHealth at 1 site in United States.
Trial summary
The purpose of this study is to determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Examination, Gynecological, Examination, Pelvic, Examination, Vaginal
- What is being tested?
- Lubricating gel used during speculum insertion. and Water used during speculum examination.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing vaginal speculum examination between the ages of 18 and 50.
Who cannot join
- Pregnancy.
- Non-English speaking.
- Using hormone therapy.
- Active vulvar or vaginal lesion, infection or complaint.
- Undergoing vaginal or vulvar procedure or biopsy.
- History of chronic pelvic pain, interstitial cystitis or vulvar vestibulitis.
- History of prior vulvar or vaginal surgical procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Obstetrics and Gynecology, Florida Hospital
Orlando, Florida, 32804
About this study
The purpose of this study is to determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water.
Read the detailed description
The outcome measure is patient discomfort as measured by a visual analogue scale.
- Being tested
- Lubricating gel used during speculum insertion., Water used during speculum examination.
- Keywords
- lubricating, gel, speculum, Pain, Pelvic, Examination, Gynecological
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubricating gel used during speculum insertion.Procedure or surgery
Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.
Water used during speculum examination.Procedure or surgery
Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
| Study group | Role | What they receive |
|---|---|---|
| Lubricating Gel | Experimental | Not described Receives: Procedure: Lubricating gel used during speculum insertion. |
| Water | Active comparator | Not described Receives: Procedure: Water used during speculum examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale.
The outcome measure is a single measurement of pain using a 10-point visual analog scale entitled "Visual Pain Scale" immediately following speculum insertion. The scale is a continuous 10cm line with the minimum value of 0 (labeled "no pain") on the left side of the line, and a maximum value of 10 (labeled "worst pain") on the right side of the line. Higher scores represent more pain and a worse outcome. There are no additional measurements obtained, and patients will not be followed for study purposes thereafter.
Measured: Immediate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Examination, GynecologicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D. Ashley Hill, MD, AdventHealth
- Investigators
- David A Hill, MD, Study chair, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289665
- Sponsor's protocol ID
- 2644-7780
- Status last verified
- Nov 2020
- First submitted
- 2 Feb 2011
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hill DA, Lamvu G. Effect of lubricating gel on patient comfort during vaginal speculum examination: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):227-31. doi: 10.1097/AOG.0b013e3182426275.
PubMed 22270273
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.
- ClinicalTrials.gov ID
- NCT01289665
- Acronym / sponsor ID
- 2644-7780
- Keywords
- lubricating, gel, speculum, Pain, Pelvic, Examination, Gynecological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Posted 17 Nov 2020
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 determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water.
Detailed description
The outcome measure is patient discomfort as measured by a visual analogue scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubricating Gel | Experimental | Procedure: Lubricating gel used during speculum insertion. |
| Water | Active comparator | Procedure: Water used during speculum examination. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing vaginal speculum examination between the ages of 18 and 50.
Key exclusion criteria (7 listed)
- Pregnancy.
- Non-English speaking.
- Using hormone therapy.
- Active vulvar or vaginal lesion, infection or complaint.
- Undergoing vaginal or vulvar procedure or biopsy.
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 |
|---|---|---|
| Lubricating gel used during speculum insertion.Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion. | Procedure or surgery | Lubricating Gel |
| Water used during speculum examination.Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion. | Procedure or surgery | Water |
Primary outcome
Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale.
Time frame: Immediate.
The outcome measure is a single measurement of pain using a 10-point visual analog scale entitled "Visual Pain Scale" immediately following speculum insertion. The scale is a continuous 10cm line with the minimum value of 0 (labeled "no pain") on the left side of the line, and a maximum value of 10 (labeled "worst pain") on the right side of the line. Higher scores represent more pain and a worse outcome. There are no additional measurements obtained, and patients will not be followed for study purposes thereafter.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22270273Hill DA, Lamvu G. Effect of lubricating gel on patient comfort during vaginal speculum examination: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):227-31. doi: 10.1097/AOG.0b013e3182426275.
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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.
David A Hill, MD study chair
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lubricating gel used during speculum insertion. and Water used during speculum examination. in people with Examination, Gynecological and Examination, Pelvic, run by AdventHealth 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 1 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 17 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 During Speculum Insertion as Measured by a Visual Analog Scale. (time frame: Immediate.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01289665, which also lists 1 linked publication.
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 17 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.