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Completed

NCT Number: NCT02945111

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

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.

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Key information

Conditions

Cervical Cancer Anxiety Anxiety Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Mental Disorders Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dschang District Hospital

Dschang, Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real-time view

Behavioral

No visual support

Behavioral

Primary outcomes

  1. Anxiety level

    Time frame: Within thirty minutes of the VIA/VILI examination

    Anxiety level will be assessed through the STAI questionnaire

Sponsors and collaborators

Lead sponsor

Prof. Patrick Petignat

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2016
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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