Audiovisual vs Verbal Information in Third Molar Surgery

NCT07528755 | Completed

• 1 other identifier: E-77082166-302.08.01-848588
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Impacted Mandibular Third Molar

Keywords

Dental Anxiety; Third Molar Surgery; Audiovisual Information; Verbal Information; Hemodynamic Parameters; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• State Anxiety Level (STAI-S)

  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)

  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 Outcomes (3)

• Heart Rate

  During the perioperative period (from baseline to immediately postoperatively)

• Blood Pressure

  During the perioperative period (from baseline to immediately postoperatively)

• Oxygen Saturation

  During the perioperative period (from baseline to immediately postoperatively)

Study Arms (2)

Audiovisual Information Group

EXPERIMENTAL

Participants received a standardized video-based audiovisual explanation of the surgical procedure before the operation.

Behavioral: Audiovisual Information

Verbal Information Group

ACTIVE COMPARATOR

Standardized verbal information about the surgical procedure was provided to participants by the clinician before surgery.

Behavioral: Verbal Information

Interventions

Audiovisual Information BEHAVIORAL

Participants watched a standardized video explaining the impacted mandibular third molar surgery procedure, including the main surgical steps, before the operation.

Audiovisual Information Group

Verbal Information BEHAVIORAL

Participants received standardized verbal information about the surgical procedure from the clinician before the operation.

Verbal Information Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

Study Officials

• Hasan Ali A ÖZTAŞ, DDS, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The surgeon performing the procedure and the investigator recording the data were blinded to group allocation. Participants were aware of the type of preoperative information they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oral and Maxillofacial Surgery

Model Details: Participants were randomly assigned to two parallel groups: an audiovisual information group and a verbal information group. Each participant received only one type of preoperative information, and outcomes were compared between the groups.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 14, 2026
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 15, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication and will be available for 5 years.
• 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.

Locations

TU (1)