Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety
1 other identifier
interventional
122
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedOctober 26, 2016
October 1, 2016
1 month
October 18, 2016
October 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Anxiety level
Anxiety level will be assessed through the STAI questionnaire
Within thirty minutes of the VIA/VILI examination
Study Arms (2)
Real-time view
EXPERIMENTALWomen 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 COMPARATORWomen 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Women not able to comply with the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dschang District Hospital
Dschang, Yaoundé, Cameroon
Related Publications (1)
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.
PMID: 31094335DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Petignat, MD
University Hospital, Geneva
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 18, 2016
First Posted
October 26, 2016
Study Start
September 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
October 26, 2016
Record last verified: 2016-10