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The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.

This study has been completed.
Sponsor:
Information provided by:
Florida Hospital
ClinicalTrials.gov Identifier:
NCT01289665
First received: February 2, 2011
Last updated: July 19, 2011
Last verified: January 2011
History of Changes

February 2, 2011
July 19, 2011
February 2011
July 2011   (final data collection date for primary outcome measure)
Patient discomfort during speculum insertion as measured by a visual analog scale. [ Time Frame: Immediate. ] [ Designated as safety issue: No ]
The outcome measure is a single measurement of pain using a 10-point visual analog scale at the time of speculum insertion. There are no additional measurements and patients will not be followed for study purposes thereafter.
Same as current
Complete list of historical versions of study NCT01289665 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.
The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.

The purpose of this study is to determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water.

The outcome measure is patient discomfort as measured by a visual analogue scale.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Examination, Gynecological
  • Examination, Pelvic
  • Examination, Vaginal
  • Procedure: 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: 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.
  • Experimental: Lubricating Gel
    Intervention: Procedure: Lubricating gel used during speculum insertion.
  • Active Comparator: Water
    Intervention: Procedure: Water used during speculum examination.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women undergoing vaginal speculum examination between the ages of 18 and 50.

Exclusion Criteria:

  • 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.
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01289665
2644-7780
No
D. Ashley Hill, M.D. Associate Director, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education., Florida Hospital
Florida Hospital
Not Provided
Study Chair: David A Hill, MD Florida Hospital
Florida Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP