Video Colposcopy in Women With Dysplasia

NCT ID: NCT02697175

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-03-31

Brief Summary

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To assess the effect of live video-colposcopy on women´s anxiety.

Detailed Description

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Conditions

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Uterine Cervical Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Live Video-Colposcopy

Women are able to observe their colposcopic examination in real-time watching a flat screen in front of them

Group Type EXPERIMENTAL

Live Video-Colposcopy

Intervention Type DEVICE

The colposcopy will be shown in real time on a flat screen

No Live Video-Colposcopy

Women are not able to observe their colposcopic examination in real-time

Group Type ACTIVE_COMPARATOR

No Live Video-Colposcopy

Intervention Type OTHER

The TV will be shut off during colposcopy

Interventions

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Live Video-Colposcopy

The colposcopy will be shown in real time on a flat screen

Intervention Type DEVICE

No Live Video-Colposcopy

The TV will be shut off during colposcopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women referred for colposcopy due to cervical abnormalities
* We included women if they attended colposcopy for the first time

Exclusion Criteria

* pregnant women
* presence of a language barrier
* known anxiety disorder or depression
* history of conization or other treatments
* known oncological disorder
* inadequate colposcopy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zydolab - Institute of Cytology and Immune Cytochemistry

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ziad Hilal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zydolab - Institute of Cytology and Immune Cytochemistry

Locations

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Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, Germany

Site Status

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Hilal Z, Alici F, Tempfer CB, Seebacher V, Rezniczek GA. Video Colposcopy for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):411-419. doi: 10.1097/AOG.0000000000002127.

Reference Type DERIVED
PMID: 28697117 (View on PubMed)

Other Identifiers

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COLPO-2

Identifier Type: -

Identifier Source: org_study_id

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