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

NCT ID: NCT02945111

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-10-31

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.

Conditions

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Cervical Cancer Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Real-time view

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

No visual support

Intervention Type BEHAVIORAL

Interventions

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Real-time view

Intervention Type BEHAVIORAL

No visual support

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Prof. Patrick Petignat

OTHER

Sponsor Role lead

Responsible Party

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Prof. Patrick Petignat

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Patrick Petignat, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Dschang District Hospital

Dschang, Yaoundé, Cameroon

Site Status

Countries

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Cameroon

References

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Camail R, Kenfack B, Tran PL, Viviano M, Tebeu PM, Temogne L, Akaaboune M, Tincho E, Mbobda J, Catarino R, Vassilakos P, Petignat P. Benefit of Watching a Live Visual Inspection of the Cervix With Acetic Acid and Lugol Iodine on Women's Anxiety: Randomized Controlled Trial of an Educational Intervention Conducted in a Low-Resource Setting. JMIR Cancer. 2019 May 13;5(1):e9798. doi: 10.2196/cancer.9798.

Reference Type DERIVED
PMID: 31094335 (View on PubMed)

Other Identifiers

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PB_2016-01745

Identifier Type: -

Identifier Source: org_study_id