Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety: a Randomized Trial of an Educational Intervention

Conditions
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Cervical Cancer, Anxiety

Intervention / Treatment
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* Behavioral: Real-time view
* Behavioral: No visual support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Women not able to comply with the study protocol.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time view<br>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. | Behavioral: Real-time view<br> <br> |
| Active Comparator: No visual support<br>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. | Behavioral: No visual support<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level | Anxiety level will be assessed through the STAI questionnaire | Within thirty minutes of the VIA/VILI examination |