Video Colposcopy in Women With Dysplasia

Uterine Cervical Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697175
• Other study ID #: COLPO-2
• Status: Completed
• Phase: N/A
• First received: February 28, 2016
• Last updated: March 22, 2017
• Start date: August 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Zydolab - Institute of Cytology and Immune Cytochemistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Hyperplasia
• Uterine Cervical Dysplasia

Intervention

Device:
• Live Video-Colposcopy
The colposcopy will be shown in real time on a flat screen

Other:
• No Live Video-Colposcopy
The TV will be shut off during colposcopy

Locations

Country	Name	City	State
Germany	Zydolab - Institute of Cytology and Immune Cytochemistry	Dortmund	NRW
Germany	Department of Obstetrics and Gynecology of the Ruhr University Bochum	Herne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Zydolab - Institute of Cytology and Immune Cytochemistry

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety score after colposcopy	Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.	10 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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