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

Not Applicable

Completed

• Conditions: Anxiety ; Dental
• Interventions: Behavioral: Information video

• Registration Number: NCT05164068
• Lead Sponsor: Universidad de Murcia

Brief Summary

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

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

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-07-01
• Study Completion: 2021-07-26
• Study First Submitted: 2021-11-22
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-17
• Last Update Submitted: 2021-12-17
• Study First Posted: 2021-12-20
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information video	Information video	The experimental group likewise consisted of 60 individuals that received information about the biopsy procedure in video format

Primary Outcome Measures

Name	Time	Method
Anxiety level comparison biopsy with two preoperative information types	1 day of Final measure of the biopsy intervention	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate patient-reported pain levels	1 day of final measure of the biopsy intervention	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.

Trial Locations

Locations (1)

Pia Lopez Jornet; 🇪🇸 Murcia, Spain