Effect of an Informative Anxiety and Stress in Patients Requiring an Oral Biopsy

Study Overview
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Brief Summary
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In clinical practice, patients scheduled for biopsy often suffer substantial stress before, during or after the procedure. In particular, most patients feel uncomfortable both with the procedure itself and with the idea of the results of the biopsy. Providing adequate information is crucial, though there is no agreement as to which is the best way to present such information. Although verbal information provided by the professional is the most common scenario, the use of written information in the form of explanatory leaflets, as well as audio recordings or videos, has also been proposed The present study was carried out at the Dental School of Universidad de San Carlos (Guatemala) to evaluate the hypothesis that an audiovisual intervention providing information on oral biopsy is able to reduce patient anxiety and stress.

Detailed Description
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A prospective, randomized clinical trial was carried out involving. A total of 120 patients were therefore finally randomized, following the Consort Statement guidelines, with the definition of two groups: a control group (n = 60) that received standard verbal information, and an experimental group (n = 60) that received information in the form of a video

Official Title
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Effect of an Informative Video Upon Anxiety and Stress in Patients Requiring an Oral Biopsy

Conditions
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Anxiety ; Dental

Intervention / Treatment
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* Behavioral: Information video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria were a patient age of over 18 years and the presence of an oral lesion/s requiring biopsy. Exclusion Criteria: Patients with decompensated systemic disorders, poor general condition, a history of psychiatric disease or psychoactive drug use were excluded, as were pregnant women and individuals failing to sign the informed consent document.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Information video<br>The experimental group likewise consisted of 60 individuals that received information about the biopsy procedure in video format | Behavioral: Information video<br>* The video contents were clear and adapted to the characteristics of the population of Guatemala. The video provided a simple description of the biopsy, its risks and benefits, complications and general recommendations, and was presented preoperatively<br>|
| No Intervention: Information face-to -face<br>The control group consisted of 60 patients that received face-to-face verbal information in a homogeneous and reproducible manner | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level comparison biopsy with two preoperative information types | Modified Dental Anxiety Scale (MDAS) was used to assess anxiety levels. The Modified Dental Anxiety Scale (MDAS) consisted of 5 questions ranging from 5 (no anxiety) to 25 (highest anxiety level). Every patient was asked to mark his or her perceived dental anxiety level on the line. | Baseline | 
| Anxiety level comparison biopsy with two preoperative information types | Modified Dental Anxiety Scale (MDAS) was used to assess anxiety levels. The Modified Dental Anxiety Scale (MDAS) consisted of 5 questions ranging from 5 (no anxiety) to 25 (highest anxiety level). Every patient was asked to mark his or her perceived dental anxiety level on the line. | 1 day of Final measure of the biopsy intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate patient-reported pain levels | The Visual Analog Scale (VAS) will be used on a 0 to 10 scale, 0 being no pain at all and 10 being the worst pain imaginable. | Baseline | 
| Evaluate patient-reported pain levels | The Visual Analog Scale (VAS) will be used on a 0 to 10 scale, 0 being no pain at all and 10 being the worst pain imaginable. | 1 day of final measure of the biopsy intervention |