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

Not Applicable

Completed

• Conditions: Cervical Cancer; Anxiety
• Interventions: Behavioral: Real-time view; Behavioral: No visual support

• Registration Number: NCT02945111
• Lead Sponsor: Prof. Patrick Petignat

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.

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 Timeline

• Study Start: 2016-09
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-24
• Last Update Submitted: 2016-10-24
• Study First Posted: 2016-10-26
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real-time view	Real-time view	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.
No visual support	No visual support	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.

Primary Outcome Measures

Name	Time	Method
Anxiety level	Within thirty minutes of the VIA/VILI examination	Anxiety level will be assessed through the STAI questionnaire

Trial Locations

Locations (1)

Dschang District Hospital; 🇨🇲 Dschang, Yaoundé, Cameroon