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CompletedNCT02697175Updated Mar 27, 2017

Video Colposcopy in Women With Dysplasia

An interventional study of Live Video-Colposcopy and No Live Video-Colposcopy in Uterine Cervical Dysplasia, sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry. Completed at 2 sites in Germany. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
275
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
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Study summary

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

02

Conditions studied

  • Uterine Cervical Dysplasia

Keywords

  • live video-colposcopy
  • cervical dysplasia
  • anxiety
  • randomized controlled trial
  • colposcopy
03

In context

Uterine Cervical Dysplasia

409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.

This study's enrollment of 275 is above the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.

Browse Uterine Cervical Dysplasia studies →

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women referred for colposcopy due to cervical abnormalities
  • We included women if they attended colposcopy for the first time

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
275 participants (actual)

Study arms

  • Experimental
    Live Video-Colposcopy

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

    Device: Live Video-Colposcopy

  • Active comparator
    No Live Video-Colposcopy

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

    Other: No Live Video-Colposcopy

Interventions

  • DeviceLive Video-Colposcopy

    The colposcopy will be shown in real time on a flat screen

  • OtherNo Live Video-Colposcopy

    The TV will be shut off during colposcopy

06

What researchers measure

Primary outcomes

  1. Anxiety score after colposcopy

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

    Time frame: 10 minutes

Secondary outcomes

  1. 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.

    Time frame: 10 minutes

  2. 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').

    Time frame: 10 minutes

  3. 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').

    Time frame: 10 minutes

  4. 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").

    Time frame: 10 minutes

  5. 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")

    Time frame: 10 minutes

  6. 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").

    Time frame: 10 minutes

  7. Overall Satisfaction

    women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").

    Time frame: 10 minutes

07

Study locations

2 sites
  • Zydolab - Institute of Cytology and Immune Cytochemistry
    Dortmund, NRW 44137, Germany
  • Department of Obstetrics and Gynecology of the Ruhr University Bochum
    Herne, NRW 44625, Germany
08

References and documents

Publications

  • 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. PubMed 28697117 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02697175
Lead sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
Responsible party
Sponsor
First posted
Mar 3, 2016
Start date
Aug 2016
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Mar 27, 2017

Study contacts

Ziad Hilal, M.D.
principal investigator · Zydolab - Institute of Cytology and Immune Cytochemistry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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