Video Colposcopy in Women With Dysplasia

N/ACompletedNCT02697175

Zydolab - Institute of Cytology and Immune Cytochemistry275 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

275

Conditions

Uterine Cervical Dysplasia

Interventions

Live Video-ColposcopyDEVICE

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

No Live Video-ColposcopyOTHER

The TV will be shut off during colposcopy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, Germany

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Anxiety score after colposcopy

Each women completes the state anxiety questionnaire (state-trait anxiety inventory \[STAI\]) 10 minutes after colposcopy.

Time frame: 10 minutes

Secondary Outcomes

Change in anxiety scores

Each women completes the state anxiety questionnaire (state-trait anxiety inventory \[STAI\]) before and 10 minutes after colposcopy. The difference in scores before and after colposcopy will be measured.

Time frame: 10 minutes

Pain during examination

women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').

Time frame: 10 minutes

Pain after examination

women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').

Time frame: 10 minutes

general unpleasantness during examination

women scores their feeeling during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("not at all unpleasant") to 10 ("extremely unpleasant").

Time frame: 10 minutes

Anxiety during examination

women scores their anxiety during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("no anxiety at all") to 10 ("worst imaginable anxiety")

Time frame: 10 minutes

Satisfaction concerning the medical consultation

women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").

Data from ClinicalTrials.gov

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