Video Colposcopy in Women With Dysplasia
Does Live Video Colposcopy Reduces Anxiety in Women With Cervical Dysplasia? A Randomised Trial.
1 other identifier
interventional
275
1 country
2
Brief Summary
To assess the effect of live video-colposcopy on women´s anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 27, 2017
March 1, 2017
7 months
February 28, 2016
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety score after colposcopy
Each women completes the state anxiety questionnaire (state-trait anxiety inventory \[STAI\]) 10 minutes after colposcopy.
10 minutes
Secondary Outcomes (7)
Change in anxiety scores
10 minutes
Pain during examination
10 minutes
Pain after examination
10 minutes
general unpleasantness during examination
10 minutes
Anxiety during examination
10 minutes
- +2 more secondary outcomes
Study Arms (2)
Live Video-Colposcopy
EXPERIMENTALWomen are able to observe their colposcopic examination in real-time watching a flat screen in front of them
No Live Video-Colposcopy
ACTIVE COMPARATORWomen are not able to observe their colposcopic examination in real-time
Interventions
The colposcopy will be shown in real time on a flat screen
Eligibility Criteria
You may qualify if:
- women referred for colposcopy due to cervical abnormalities
- We included women if they attended colposcopy for the first time
You may not qualify if:
- pregnant women
- presence of a language barrier
- known anxiety disorder or depression
- history of conization or other treatments
- known oncological disorder
- inadequate colposcopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Zydolab - Institute of Cytology and Immune Cytochemistry
Dortmund, North Rhine-Westphalia, 44137, Germany
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625, Germany
Related Publications (1)
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.
PMID: 28697117DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziad Hilal, M.D.
Zydolab - Institute of Cytology and Immune Cytochemistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2016
First Posted
March 3, 2016
Study Start
August 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 27, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share