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

Prof. Patrick Petignat

Status: Completed

Conditions: Anxiety; Cervical Cancer

Treatments: Behavioral: No visual support; Behavioral: Real-time view

Study type: Interventional

Funder types: Other

Identifiers

NCT02945111

PB_2016-01745

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: Female

Ages: 30 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

122 participants in 2 patient groups

Real-time view

Experimental group

Description:

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.

Treatment:

Behavioral: Real-time view

No visual support

Active Comparator group

Description:

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.

Treatment:

Behavioral: No visual support