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Completed

NCT Number: NCT01289665

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.

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Key information

Conditions

Examination, Gynecological Examination, Pelvic Examination, Vaginal Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Florida Hospital

Orlando, Florida, 32804, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lubricating gel used during speculum insertion.

Procedure

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

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.

Primary outcomes

  1. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 4, 2011
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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