Audiovisual vs Verbal Information in Third Molar Surgery (AVID)

April 9, 2026 updated by: Gökhan Hakkı ALPASLAN, Gazi University

Effect of Audiovisual Versus Verbal Preoperative Information on Dental Anxiety and Hemodynamic Parameters in Patients Undergoing Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial

This study evaluates whether audiovisual (video-based) or verbal preoperative information is more effective in reducing dental anxiety and stabilizing physiological responses in patients undergoing impacted mandibular third molar surgery.

A total of 73 patients scheduled for third molar extraction were randomly assigned to receive either video-based information or standard verbal information before surgery. Anxiety levels were assessed using validated scales, and physiological parameters such as heart rate, blood pressure, and oxygen saturation were recorded at different stages of the surgical procedure.

The aim of this study is to determine whether the method of preoperative information has an effect on patients' anxiety levels and physiological stress responses during oral surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective randomized controlled clinical trial was conducted to evaluate the effects of audiovisual and verbal preoperative information on dental anxiety and hemodynamic parameters in patients undergoing impacted mandibular third molar surgery.

A total of 73 patients scheduled for impacted mandibular third molar extraction were included in the study and randomly assigned to one of two groups: an audiovisual information group (video-based information) and a verbal information group. The audiovisual group received a standardized video presentation explaining the surgical procedure, while the control group received standardized verbal information from the clinician.

Dental anxiety levels were assessed using validated psychometric scales, including the Modified Dental Anxiety Scale (MDAS) and the State-Trait Anxiety Inventory (STAI-S and STAI-T). In addition, physiological parameters such as heart rate, systolic and diastolic blood pressure, and oxygen saturation were recorded at standardized stages of the surgical procedure, including preoperative baseline, anesthesia administration, incision, tooth extraction, suturing, and postoperative period.

The primary objective of the study was to compare the effects of audiovisual and verbal information on dental anxiety levels. Secondary outcomes included the evaluation of hemodynamic parameters during different surgical stages. The study also explored the influence of demographic factors such as age and sex on anxiety and physiological responses.

This study was approved by the Ethics Committee of Gazi University (Decision No: E-77082166-302.08.01-848588), and all participants provided written informed consent prior to inclusion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06500
        • Gazi University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients scheduled for impacted mandibular third molar extraction
  • Age between 18 and 50 years
  • Literate individuals
  • Mentally healthy individuals
  • Individuals without systemic disease
  • Willingness to participate voluntarily and provide written informed consent

Exclusion Criteria:

  • Age under 18 years
  • Illiterate individuals
  • Individuals with psychiatric disorders
  • Individuals who declined to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Audiovisual Information Group
Participants received a standardized video-based audiovisual explanation of the surgical procedure before the operation.
Behavioral: Audiovisual Information
Participants watched a standardized video explaining the impacted mandibular third molar surgery procedure, including the main surgical steps, before the operation.
Active Comparator: Verbal Information Group
Standardized verbal information about the surgical procedure was provided to participants by the clinician before surgery.
Behavioral: Verbal Information
Participants received standardized verbal information about the surgical procedure from the clinician before the operation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
State Anxiety Level (STAI-S)
Time Frame: Baseline (preoperative) and immediately after surgery
State anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S), a validated 20-item questionnaire with scores ranging from 20 to 80, where higher scores indicate greater anxiety (worse outcome). Measurements were performed at baseline (preoperative) and after the intervention (preoperative, following audiovisual or verbal information.
Baseline (preoperative) and immediately after surgery
Dental Anxiety Level (MDAS)
Time Frame: Baseline (preoperative) and immediately postoperatively
Dental anxiety was assessed using the Modified Dental Anxiety Scale (MDAS), a validated 5-item questionnaire with scores ranging from 5 to 25, where higher scores indicate greater dental anxiety (worse outcome). Measurements were performed at baseline (preoperative) and immediately postoperatively.
Baseline (preoperative) and immediately postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: During the perioperative period (from baseline to immediately postoperatively)
Heart rate (beats per minute) was measured using a non-invasive patient monitoring device at standardized perioperative time points. Measurements were obtained at baseline (preoperative), during local anesthesia administration, surgical incision, tooth extraction, suturing, and immediately after completion of the procedure. Higher heart rate values indicate increased physiological stress response associated with the surgical intervention.
During the perioperative period (from baseline to immediately postoperatively)
Blood Pressure
Time Frame: During the perioperative period (from baseline to immediately postoperatively)
Blood pressure (mmHg), including systolic and diastolic values, was measured using a non-invasive patient monitoring device at standardized perioperative time points, including baseline (preoperative), during local anesthesia administration, surgical incision, tooth extraction, suturing, and immediately after completion of the procedure. Higher values indicate increased cardiovascular response to surgical stress.
During the perioperative period (from baseline to immediately postoperatively)
Oxygen Saturation
Time Frame: During the perioperative period (from baseline to immediately postoperatively)
Oxygen saturation (%) was measured using a non-invasive patient monitoring device at standardized perioperative time points, including baseline (preoperative), during local anesthesia administration, surgical incision, tooth extraction, suturing, and immediately after completion of the procedure. Values represent the percentage of oxygen-saturated hemoglobin in the blood. Lower values may indicate impaired oxygenation and altered physiological response, whereas higher values reflect adequate oxygenation status. Changes in oxygen saturation may also reflect physiological responses associated with perioperative stress.
During the perioperative period (from baseline to immediately postoperatively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hasan Ali A ÖZTAŞ, DDS, PhD, Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-77082166-302.08.01-848588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the reported results, including demographic data, anxiety scale scores (MDAS, STAI-S, STAI-T), and hemodynamic parameters (heart rate, blood pressure, and oxygen saturation), will be shared upon reasonable request.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication and will be available for 5 years.

IPD Sharing Access Criteria

Access to de-identified individual participant data will be granted to researchers who provide a reasonable scientific request. Requests should be directed to the corresponding author. Data will be shared after approval by the research team and in accordance with ethical and data protection regulations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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