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Video Colposcopy in Women With Dysplasia

Primary Purpose

Uterine Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Live Video-Colposcopy
No Live Video-Colposcopy
Sponsored by
Zydolab - Institute of Cytology and Immune Cytochemistry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Uterine Cervical Dysplasia focused on measuring live video-colposcopy, cervical dysplasia, anxiety, randomized controlled trial, colposcopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zydolab - Institute of Cytology and Immune Cytochemistry
  • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Live Video-Colposcopy

No Live Video-Colposcopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2016
Last Updated
March 22, 2017
Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
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1. Study Identification

Unique Protocol Identification Number
NCT02697175
Brief Title
Video Colposcopy in Women With Dysplasia
Official Title
Does Live Video Colposcopy Reduces Anxiety in Women With Cervical Dysplasia? A Randomised Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia
Keywords
live video-colposcopy, cervical dysplasia, anxiety, randomized controlled trial, colposcopy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live Video-Colposcopy
Arm Type
Experimental
Arm Description
Women are able to observe their colposcopic examination in real-time watching a flat screen in front of them
Arm Title
No Live Video-Colposcopy
Arm Type
Active Comparator
Arm Description
Women are not able to observe their colposcopic examination in real-time
Intervention Type
Device
Intervention Name(s)
Live Video-Colposcopy
Intervention Description
The colposcopy will be shown in real time on a flat screen
Intervention Type
Other
Intervention Name(s)
No Live Video-Colposcopy
Intervention Description
The TV will be shut off during colposcopy
Primary Outcome Measure Information:
Title
Anxiety score after colposcopy
Description
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Change in anxiety scores
Description
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
Title
Pain during examination
Description
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
Title
Pain after examination
Description
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
Title
general unpleasantness during examination
Description
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
Title
Anxiety during examination
Description
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
Title
Satisfaction concerning the medical consultation
Description
women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").
Time Frame
10 minutes
Title
Overall Satisfaction
Description
women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").
Time Frame
10 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziad Hilal, M.D.
Organizational Affiliation
Zydolab - Institute of Cytology and Immune Cytochemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zydolab - Institute of Cytology and Immune Cytochemistry
City
Dortmund
State/Province
NRW
ZIP/Postal Code
44137
Country
Germany
Facility Name
Department of Obstetrics and Gynecology of the Ruhr University Bochum
City
Herne
State/Province
NRW
ZIP/Postal Code
44625
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28697117
Citation
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.
Results Reference
derived

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Video Colposcopy in Women With Dysplasia

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