Video Colposcopy in Women With Dysplasia

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

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

Conditions
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Uterine Cervical Dysplasia

Intervention / Treatment
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* Device: Live Video-Colposcopy
* Other: No Live Video-Colposcopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score after colposcopy | 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 | 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 | 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 | 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 | 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 | 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 | 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 | women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (maximally unsatisfied) to 10 (maximally satisfied). | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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live video-colposcopy, cervical dysplasia, anxiety, randomized controlled trial, colposcopy