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

NCT ID: NCT01289665

Last Updated: 2020-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-07-31

Brief Summary

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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

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

Conditions

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Examination, Gynecological Examination, Pelvic Examination, Vaginal

Keywords

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lubricating gel speculum Pain, Pelvic Examination, Gynecological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lubricating Gel

Group Type EXPERIMENTAL

Lubricating gel used during speculum insertion.

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Water used during speculum examination.

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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D. Ashley Hill, MD

Associate Director, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A Hill, MD

Role: STUDY_CHAIR

AdventHealth

Locations

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Department of Obstetrics and Gynecology, Florida Hospital

Orlando, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22270273 (View on PubMed)

Other Identifiers

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2644-7780

Identifier Type: -

Identifier Source: org_study_id