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OpenTrials
Completed

NCT Number: NCT02697175

Video Colposcopy in Women With Dysplasia

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

Completed

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Key information

Conditions

Uterine Cervical Dysplasia Anxiety Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zydolab - Institute of Cytology and Immune Cytochemistry, Dortmund, North Rhine-Westphalia, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Live Video-Colposcopy

Device

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

No Live Video-Colposcopy

Other

The TV will be shut off during colposcopy

Primary outcomes

  1. Anxiety score after colposcopy

    Time frame: 10 minutes

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

Secondary outcomes

  1. Change in anxiety scores

    Time frame: 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.

  2. Pain during examination

    Time frame: 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').

  3. Pain after examination

    Time frame: 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').

  4. general unpleasantness during examination

    Time frame: 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").

  5. Anxiety during examination

    Time frame: 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")

  6. Satisfaction concerning the medical consultation

    Time frame: 10 minutes

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

  7. Overall Satisfaction

    Time frame: 10 minutes

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

Sponsors and collaborators

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2016
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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