Video Colposcopy in Women With Dysplasia

Zydolab - Institute of Cytology and Immune Cytochemistry

Status: Completed

Conditions: Uterine Cervical Dysplasia

Treatments: Other: No Live Video-Colposcopy; Device: Live Video-Colposcopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02697175

COLPO-2

Details and patient eligibility

About

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

Enrollment: 275 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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275 participants in 2 patient groups

Live Video-Colposcopy

Experimental group

Description:

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

Treatment:

Device: Live Video-Colposcopy

No Live Video-Colposcopy

Active Comparator group

Description:

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

Treatment:

Other: No Live Video-Colposcopy