Cervical CancerNCT02945111
Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety
A study testing Real-time view and No visual support in people with Cervical Cancer and Anxiety, run by Prof. Patrick Petignat at 1 site in Cameroon.
Trial summary
The purpose of this study is to assess whether the degree of anxiety experienced by women undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced by watching the procedure in real-time on a digital screen. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women only
- Conditions the study is for
- Cervical Cancer, Anxiety
- What is being tested?
- Real-time view and No visual support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteCameroon
- Study dates
- Sep 2016to Oct 2016
- 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 30 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women participating in a cervical cancer screening campaign organized by the District hospital of Dschang
- Women understanding the study procedure and accepting voluntarily to participate by signing an informed consent form (ICF).
Who cannot join
- Women not able to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety: a Randomized Trial of an Educational Intervention
The purpose of this study is to assess whether the degree of anxiety experienced by women undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced by watching the procedure in real-time on a digital screen.
Read the detailed description
The study took place in the District of Dschang, Cameroon. Women aged between 30 and 49 years, addressed to undergo a pelvic examination with VIA and VILI, were invited to participate. Throughout the examination, one part of the women underwent the routine VIA/VILI, with no visual support (control group), whereas the other part of patients were shown the pictures of the cervix in real-time on a digital screen (study group). At the end of the procedure, all women had the possibility to see the pictures retrospectively. Randomization determined the women's distribution between the two groups. Their anxiety level was measured by asking them to complete the Spielberg's State Anxiety Inventory (STAI) both prior to and immediately after the procedure.
- Conditions
- Cervical Cancer, Anxiety
- Being tested
- Real-time view, No visual support
- Medical subject headings
- Uterine Cervical Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time viewBehavioural
No visual supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Real-time view | Experimental | Women undergoing Visual Inspection with Acetic Acid (VIA) and Lugol's Iodine (VILI) will watch the cervical images taken throughout the examination in real-time on a digital screen. The patients' anxiety level both before and after the examination will be measured using the Spielberg's State Anxiety Inventory. Receives: Behavioral: Real-time view |
| No visual support | Active comparator | Women in this arm will undergo Visual Inspection with Acetic Acid (VIA) and Lugol's Iodine (VILI) without any visual support. Their anxiety level both before and after the examination will be measured using the Spielberg's State Anxiety Inventory. Receives: Behavioral: No visual support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Anxiety level will be assessed through the STAI questionnaire
Measured: Within thirty minutes of the VIA/VILI examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionOct 2016
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 Cervical CancerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Patrick Petignat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Patrick Petignat, University Hospital, Geneva
- Investigators
- Patrick Petignat, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945111
- Sponsor's protocol ID
- PB_2016-01745
- Status last verified
- Oct 2016
- First submitted
- 18 Oct 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Camail R, Kenfack B, Tran PL, Viviano M, Tebeu PM, Temogne L, Akaaboune M, Tincho E, Mbobda J, Catarino R, Vassilakos P, Petignat P. Benefit of Watching a Live Visual Inspection of the Cervix With Acetic Acid and Lugol Iodine on Women's Anxiety: Randomized Controlled Trial of an Educational Intervention Conducted in a Low-Resource Setting. JMIR Cancer. 2019 May 13;5(1):e9798. doi: 10.2196/cancer.9798.
PubMed 31094335
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety: a Randomized Trial of an Educational Intervention
- ClinicalTrials.gov ID
- NCT02945111
- Acronym / sponsor ID
- PB_2016-01745
- Conditions
- Cervical Cancer, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Prof. Patrick PetignatUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Oct 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.
The purpose of this study is to assess whether the degree of anxiety experienced by women undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced by watching the procedure in real-time on a digital screen.
Detailed description
The study took place in the District of Dschang, Cameroon. Women aged between 30 and 49 years, addressed to undergo a pelvic examination with VIA and VILI, were invited to participate. Throughout the examination, one part of the women underwent the routine VIA/VILI, with no visual support (control group), whereas the other part of patients were shown the pictures of the cervix in real-time on a digital screen (study group). At the end of the procedure, all women had the possibility to see the pictures retrospectively. Randomization determined the women's distribution between the two groups. Their anxiety level was measured by asking them to complete the Spielberg's State Anxiety Inventory (STAI) both prior to and immediately after the procedure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time view | Experimental | Behavioral: Real-time viewWomen undergoing Visual Inspection with Acetic Acid (VIA) and Lugol's Iodine (VILI) will watch the cervical images taken throughout the examination in real-time on a digital screen. The patients' anxiety level both before and after the examination will be measured using the Spielberg's State Anxiety Inventory. |
| No visual support | Active comparator | Behavioral: No visual supportWomen in this arm will undergo Visual Inspection with Acetic Acid (VIA) and Lugol's Iodine (VILI) without any visual support. Their anxiety level both before and after the examination will be measured using the Spielberg's State Anxiety Inventory. |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women participating in a cervical cancer screening campaign organized by the District hospital of Dschang
- Women understanding the study procedure and accepting voluntarily to participate by signing an informed consent form (ICF).
Key exclusion criteria (1 listed)
- Women not able to comply with the study protocol.
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 |
|---|---|---|
| Real-time view | Behavioural | Real-time view |
| No visual support | Behavioural | No visual support |
Primary outcome
Anxiety level
Time frame: Within thirty minutes of the VIA/VILI examination
Anxiety level will be assessed through the STAI questionnaire
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 26 Oct 2016.
- Derived from this study: PubMed 31094335Camail R, Kenfack B, Tran PL, Viviano M, Tebeu PM, Temogne L, Akaaboune M, Tincho E, Mbobda J, Catarino R, Vassilakos P, Petignat P. Benefit of Watching a Live Visual Inspection of the Cervix With Acetic Acid and Lugol Iodine on Women's Anxiety: Randomized Controlled Trial of an Educational Intervention Conducted in a Low-Resource Setting. JMIR Cancer. 2019 May 13;5(1):e9798. doi: 10.2196/cancer.9798.
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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.
Patrick Petignat, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time view and No visual support in people with Cervical Cancer and Anxiety, run by Prof. Patrick Petignat at 1 site in Cameroon.
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 1 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. 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 level (time frame: Within thirty minutes of the VIA/VILI examination). 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 NCT02945111, 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 26 Oct 2016.