NCT05164068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

November 22, 2021

Last Update Submit

December 17, 2021

Conditions

Anxiety ; Dental

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Evaluate patient-reported pain levels

    Baseline

  • Evaluate patient-reported pain levels

    1 day of final measure of the biopsy intervention

Study Arms (2)

Information video

EXPERIMENTAL

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

Behavioral: Information video

Information face-to -face

NO INTERVENTION

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

Interventions

Information videoBEHAVIORAL

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 video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pia Lopez Jornet

Murcia, 30008, Spain

Location

Related Publications (2)

  • 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.

    PMID: 28106507BACKGROUND

  • 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.

    PMID: 29558935BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador principal Head Oral Medicine

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 20, 2021

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 26, 2021

Last Updated

December 20, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)