Effect of an Informative Video Upon Anxiety and Stress in Patients Requiring an Oral Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Murcia
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Anxiety level comparison biopsy with two preoperative information types
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Information video
The experimental group likewise consisted of 60 individuals that received information about the biopsy procedure in video format
Intervention: Information video (Behavioral)
Information face-to -face
The control group consisted of 60 patients that received face-to-face verbal information in a homogeneous and reproducible manner
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.
Anxiety level comparison biopsy with two preoperative information types
Time Frame: Baseline
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)
- Evaluate patient-reported pain levels(Baseline)
Investigators
Pia Lopez Jornet
Investigador principal Head Oral Medicine
Universidad de Murcia