Clinical trial NCT05164068: Effect of an Informative Anxiety and Stress in Patients Requiring an Oral Biopsy
Official title: Effect of an Informative Video Upon Anxiety and Stress in Patients Requiring an Oral Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety ; Dental
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Anxiety level comparison biopsy with two preoperative information types
timeFrame: Baseline
measure: Anxiety level comparison biopsy with two preoperative information types
timeFrame: 1 day of Final measure of the biopsy intervention
Secondary outcomes:
measure: Evaluate patient-reported pain levels
timeFrame: Baseline
measure: Evaluate patient-reported pain levels
timeFrame: 1 day of final measure of the biopsy intervention
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Pia Lopez Jornet
Study officials:
References:
citation: 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.
citation: 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.