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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
  Purpose

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


Condition Intervention
Examination, Gynecological
Examination, Pelvic
Examination, Vaginal
 Procedure: Lubricating gel used during speculum insertion.
Procedure: Water used during speculum examination.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: February 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubricating Gel 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.
Active Comparator: Water 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.

Detailed Description:

The outcome measure is patient discomfort as measured by a visual analogue scale.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289665

Locations
United States, Florida
Department of Obstetrics and Gynecology, Florida Hospital
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Florida Hospital
Investigators
Study Chair: David A Hill, MD Florida Hospital
  More Information

No publications provided by Florida Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: D. Ashley Hill, M.D. Associate Director, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education., Florida Hospital
ClinicalTrials.gov Identifier: NCT01289665     History of Changes
Other Study ID Numbers: 2644-7780
Study First Received: February 2, 2011
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Hospital:
lubricating
gel
speculum
Pain, Pelvic
Examination, Gynecological

ClinicalTrials.gov processed this record on May 16, 2013