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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945111
• Other study ID #: PB_2016-01745
• Status: Completed
• Phase: N/A
• First received: October 18, 2016
• Last updated: October 24, 2016
• Start date: September 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Real-time view

• No visual support

Locations

Country	Name	City	State
Cameroon	Dschang District Hospital	Dschang	Yaoundé

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Patrick Petignat

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level	Anxiety level will be assessed through the STAI questionnaire	Within thirty minutes of the VIA/VILI examination	No