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

U

Universidad de Murcia

Status

Completed

Conditions

Anxiety ; Dental

Treatments

Behavioral: Information video

Study type

Interventional

Funder types

Other

Identifiers

NCT05164068
adcobiusac 023-2021

Details and patient eligibility

About

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.

Full 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

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

Information video
Experimental group
Description:
The experimental group likewise consisted of 60 individuals that received information about the biopsy procedure in video format
Treatment:
Behavioral: Information video
Information face-to -face
No Intervention group
Description:
The control group consisted of 60 patients that received face-to-face verbal information in a homogeneous and reproducible manner

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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