- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07528755
Audiovisual vs Verbal Information in Third Molar Surgery (AVID)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06500
- Gazi University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Audiovisual Information Group
Participants received a standardized video-based audiovisual explanation of the surgical procedure before the operation.
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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.
|
Participants received standardized verbal information about the surgical procedure from the clinician before the operation.
|
What is the study measuring?
Primary Outcome Measures
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
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.
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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.
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During the perioperative period (from baseline to immediately postoperatively)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hasan Ali A ÖZTAŞ, DDS, PhD, Gazi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-77082166-302.08.01-848588
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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