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

NCT ID: NCT05164068

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-07-26

Brief Summary

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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

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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

Conditions

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Anxiety ; Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Information video

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

Group Type EXPERIMENTAL

Information video

Intervention Type BEHAVIORAL

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

Information face-to -face

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Pia Lopez Jornet

Investigador principal Head Oral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pia Lopez Jornet

Murcia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 28106507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29558935 (View on PubMed)

Other Identifiers

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adcobiusac 023-2021

Identifier Type: -

Identifier Source: org_study_id