Video Colposcopy in Women With Dysplasia

Not Applicable

Completed

• Conditions: Uterine Cervical Dysplasia
• Interventions: Other: No Live Video-Colposcopy; Device: Live Video-Colposcopy

• Registration Number: NCT02697175
• Lead Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-28
• Study First Submitted QC: 2016-02-28
• Study First Posted: 2016-03-03
• Study Start: 2016-08
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 275

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Live Video-Colposcopy	No Live Video-Colposcopy	Women are not able to observe their colposcopic examination in real-time
Live Video-Colposcopy	Live Video-Colposcopy	Women are able to observe their colposcopic examination in real-time watching a flat screen in front of them

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain after examination	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').
Change in anxiety scores	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.
Pain during examination	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').
Anxiety during examination	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")
Satisfaction concerning the medical consultation	10 minutes	women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").
general unpleasantness during examination	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").
Overall Satisfaction	10 minutes	women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").

Trial Locations

Locations (2)

Zydolab - Institute of Cytology and Immune Cytochemistry; 🇩🇪 Dortmund, NRW, Germany

Department of Obstetrics and Gynecology of the Ruhr University Bochum; 🇩🇪 Herne, NRW, Germany