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

AdventHealth

Status: Completed

Conditions: Examination, Gynecological; Examination, Vaginal; Examination, Pelvic

Treatments: Procedure: Water used during speculum examination.; Procedure: Lubricating gel used during speculum insertion.

Study type: Interventional

Funder types: Other

Identifiers

NCT01289665

2644-7780

Details and patient eligibility

About

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

Full description

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

Enrollment: 120 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Lubricating Gel

Experimental group

Treatment:

Procedure: Lubricating gel used during speculum insertion.

Water

Active Comparator group

Treatment:

Procedure: Water used during speculum examination.