Uterine Cervical DysplasiaNCT02697175
Video Colposcopy in Women With Dysplasia
A study testing Live Video-Colposcopy and No Live Video-Colposcopy in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 2 sites in Germany.
Trial summary
To assess the effect of live video-colposcopy on women´s anxiety. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Uterine Cervical Dysplasia
- What is being tested?
- Live Video-Colposcopy and No Live Video-Colposcopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women referred for colposcopy due to cervical abnormalities
- We included women if they attended colposcopy for the first time
Who cannot join
- pregnant women
- presence of a language barrier
- known anxiety disorder or depression
- history of conization or other treatments
- known oncological disorder
- inadequate colposcopy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Zydolab - Institute of Cytology and Immune Cytochemistry
Dortmund, North Rhine-Westphalia, 44137
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625
About this study
Official title: Does Live Video Colposcopy Reduces Anxiety in Women With Cervical Dysplasia? A Randomised Trial.
To assess the effect of live video-colposcopy on women´s anxiety.
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- Live Video-Colposcopy, No Live Video-Colposcopy
- Keywords
- live video-colposcopy, cervical dysplasia, anxiety, randomized controlled trial, colposcopy
- Medical subject headings
- Uterine Cervical Dysplasia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Video-ColposcopyDevice
The colposcopy will be shown in real time on a flat screen
No Live Video-ColposcopyOther
The TV will be shut off during colposcopy
| Study group | Role | What they receive |
|---|---|---|
| Live Video-Colposcopy | Experimental | Women are able to observe their colposcopic examination in real-time watching a flat screen in front of them Receives: Device: Live Video-Colposcopy |
| No Live Video-Colposcopy | Active comparator | Women are not able to observe their colposcopic examination in real-time Receives: Other: No Live Video-Colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety score after colposcopy
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
Measured: 10 minutes
Secondary outcomes (7)
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.
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').
Measured: 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').
Measured: 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").
Measured: 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")
Measured: 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").
Measured: 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").
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydolab - Institute of Cytology and Immune Cytochemistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziad Hilal, M.D., Principal investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697175
- Sponsor's protocol ID
- COLPO-2
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Live Video Colposcopy Reduces Anxiety in Women With Cervical Dysplasia? A Randomised Trial.
- ClinicalTrials.gov ID
- NCT02697175
- Acronym / sponsor ID
- COLPO-2
- Conditions
- Uterine Cervical Dysplasia
- Keywords
- live video-colposcopy, cervical dysplasia, anxiety, randomized controlled trial, colposcopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Zydolab - Institute of Cytology and Immune CytochemistryUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of live video-colposcopy on women´s anxiety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live Video-Colposcopy | Experimental | Device: Live Video-ColposcopyWomen are able to observe their colposcopic examination in real-time watching a flat screen in front of them |
| No Live Video-Colposcopy | Active comparator | Other: No Live Video-ColposcopyWomen are not able to observe their colposcopic examination in real-time |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women referred for colposcopy due to cervical abnormalities
- We included women if they attended colposcopy for the first time
Key exclusion criteria (6 listed)
- pregnant women
- presence of a language barrier
- known anxiety disorder or depression
- history of conization or other treatments
- known oncological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Video-ColposcopyThe colposcopy will be shown in real time on a flat screen | Device | Live Video-Colposcopy |
| No Live Video-ColposcopyThe TV will be shut off during colposcopy | Other | No Live Video-Colposcopy |
Primary outcome
Anxiety score after colposcopy
Time frame: 10 minutes
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
7 secondary outcomes
Change in anxiety scores
Time frame: 10 minutes
Pain during examination
Time frame: 10 minutes
Pain after examination
Time frame: 10 minutes
general unpleasantness during examination
Time frame: 10 minutes
Anxiety during examination
Time frame: 10 minutes
Satisfaction concerning the medical consultation
Time frame: 10 minutes
Overall Satisfaction
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Derived from this study: PubMed 28697117Hilal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziad Hilal, M.D. principal investigator
Zydolab - Institute of Cytology and Immune Cytochemistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Video-Colposcopy and No Live Video-Colposcopy in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety score after colposcopy (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02697175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.