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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety ; Dental
• Intervention / Treatment: Behavioral: Information video

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30008
    • Pia Lopez Jornet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Information video; The experimental group likewise consisted of 60 individuals that received information about the biopsy procedure in video format	Behavioral: Information video; 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
No Intervention: Information face-to -face; 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?

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

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Publications and helpful links

General Publications

• Lin CS, Wu SY, Yi CA. Association between Anxiety and Pain in Dental Treatment: A Systematic Review and Meta-analysis. J Dent Res. 2017 Feb;96(2):153-162. doi: 10.1177/0022034516678168. Epub 2016 Nov 16.
• Caltabiano ML, Croker F, Page L, Sklavos A, Spiteri J, Hanrahan L, Choi R. Dental anxiety in patients attending a student dental clinic. BMC Oral Health. 2018 Mar 20;18(1):48. doi: 10.1186/s12903-018-0507-5.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 26, 2021

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: adcobiusac 023-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No