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

Primary Purpose

Anxiety ; Dental

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Information video
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety ; Dental

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pia Lopez Jornet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Information video

Information face-to -face

Arm Description

The experimental group likewise consisted of 60 individuals that received information about the biopsy procedure in video format

The control group consisted of 60 patients that received face-to-face verbal information in a homogeneous and reproducible manner

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 22, 2021
Last Updated
December 17, 2021
Sponsor
Universidad de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT05164068
Brief Title
Effect of an Informative Anxiety and Stress in Patients Requiring an Oral Biopsy
Acronym
Anxiety
Official Title
Effect of an Informative Video Upon Anxiety and Stress in Patients Requiring an Oral Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety ; Dental

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Information video
Arm Type
Experimental
Arm Description
The experimental group likewise consisted of 60 individuals that received information about the biopsy procedure in video format
Arm Title
Information face-to -face
Arm Type
No Intervention
Arm Description
The control group consisted of 60 patients that received face-to-face verbal information in a homogeneous and reproducible manner
Intervention Type
Behavioral
Intervention Name(s)
Information video
Intervention Description
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
Primary Outcome Measure Information:
Title
Anxiety level comparison biopsy with two preoperative information types
Description
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.
Time Frame
Baseline
Title
Anxiety level comparison biopsy with two preoperative information types
Description
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.
Time Frame
1 day of Final measure of the biopsy intervention
Secondary Outcome Measure Information:
Title
Evaluate patient-reported pain levels
Description
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.
Time Frame
Baseline
Title
Evaluate patient-reported pain levels
Description
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.
Time Frame
1 day of final measure of the biopsy intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Pia Lopez Jornet
City
Murcia
ZIP/Postal Code
30008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28106507
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.
Results Reference
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PubMed Identifier
29558935
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.
Results Reference
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Effect of an Informative Anxiety and Stress in Patients Requiring an Oral Biopsy

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