Video Colposcopy in Women With Dysplasia

March 22, 2017 updated by: Zydolab - Institute of Cytology and Immune Cytochemistry

Does Live Video Colposcopy Reduces Anxiety in Women With Cervical Dysplasia? A Randomised Trial.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Dortmund, NRW, Germany, 44137
        • Zydolab - Institute of Cytology and Immune Cytochemistry
      • Herne, NRW, Germany, 44625
        • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Live Video-Colposcopy
Women are able to observe their colposcopic examination in real-time watching a flat screen in front of them
Device: Live Video-Colposcopy
The colposcopy will be shown in real time on a flat screen
ACTIVE_COMPARATOR: No Live Video-Colposcopy
Women are not able to observe their colposcopic examination in real-time
Other: No Live Video-Colposcopy
The TV will be shut off during colposcopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety score after colposcopy
Time Frame: 10 minutes
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety scores
Time Frame: 10 minutes
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.
10 minutes
Pain during examination
Time Frame: 10 minutes
women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
10 minutes
Pain after examination
Time Frame: 10 minutes
women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
10 minutes
general unpleasantness during examination
Time Frame: 10 minutes
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").
10 minutes
Anxiety during examination
Time Frame: 10 minutes
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")
10 minutes
Satisfaction concerning the medical consultation
Time Frame: 10 minutes
women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").
10 minutes
Overall Satisfaction
Time Frame: 10 minutes
women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

February 28, 2016

First Submitted That Met QC Criteria

February 28, 2016

First Posted (ESTIMATE)

March 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLPO-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Cervical Dysplasia

Clinical Trials on Live Video-Colposcopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe