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Clinical Trials/NCT05164068
NCT05164068
Completed
Not Applicable

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

Universidad de Murcia1 site in 1 country120 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety ; Dental
Sponsor
Universidad de Murcia
Enrollment
120
Locations
1
Primary Endpoint
Anxiety level comparison biopsy with two preoperative information types
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
July 26, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pia Lopez Jornet

Investigador principal Head Oral Medicine

Universidad de Murcia

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anxiety level comparison biopsy with two preoperative information types

Time Frame: 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 Outcomes

  • Evaluate patient-reported pain levels(1 day of final measure of the biopsy intervention)

Study Sites (1)

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