Visual Tools and Preoperative Anxiety in Orthognathic Surgery

NCT07394881 | Completed

• 1 other identifier: 24/159
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether adding visual tools to standard preoperative counseling can reduce anxiety in patients scheduled for bimaxillary orthognathic surgery. Participants aged 18-36 years undergoing elective surgery was randomly assigned to one of three groups: (1) standard verbal information, (2) standard verbal information with a short animation video, (3) standard verbal information with a 3-D anatomical skull model demonstration. Anxiety was assessed using the State-Trait Anxiety Inventory and a visual analog scale at two time points: before the information session and approximately one hour before surgery. The goal is to determine whether visual tools provide additional benefit beyond standard counseling in reducing preoperative anxiety.

Conditions

Preoperative Anxiety; Orthognathic Surgical Procedures

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale for Anxiety (VAS-A)

  Change in preoperative anxiety level measured using the Visual Analogue Scale for Anxiety (VAS-A). The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).

  From baseline (before preoperative counseling) to immediately before surgery

• State-Trait Anxiety Inventory

  Change in state anxiety measured using the State subscale of the State-Trait Anxiety Inventory (STAI-S). The overall (total) score for STAI ranges from a minimum of 20 to a maximum of 80; STAI scores are commonly classified as 'no or low anxiety' (20-37), 'moderate anxiety' (38-44), and 'high anxiety' (45-80)

  From baseline (before preoperative counseling) to immediately before surgery

Study Arms (3)

Control

ACTIVE COMPARATOR

Standardized verbal preoperative information.

Behavioral: Verbal İnformation

Video Animation Tools

EXPERIMENTAL

animation video used as a visual tool during counseling.

Behavioral: Animation Video Counseling

3D-Head Skull Tools

EXPERIMENTAL

Anatomical skull model demonstration used as a visual tool during counseling.

Behavioral: 3-D Skull Model Counseling

Interventions

Animation Video Counseling BEHAVIORAL

Standardized preoperative verbal counseling supplemented with an animation video explaining the surgical procedure and potential complications.

Video Animation Tools

3-D Skull Model Counseling BEHAVIORAL

Standardized preoperative verbal counseling supplemented with a 3-D anatomical skull model demonstration to explain surgical anatomy and the planned procedure.

3D-Head Skull Tools

Verbal İnformation BEHAVIORAL

Standardized preoperative verbal information provided to all participants.

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (≥18 years).
• Scheduled to undergo elective bimaxillary orthognathic surgery under general anesthesia.
• Able to understand the study procedures and complete the anxiety questionnaires.
• Provided written informed consent.

You may not qualify if:

• Current diagnosis of a major psychiatric disorder or use of anxiolytic/antidepressant medication that could affect anxiety assessment.
• Cognitive impairment or inability to complete the questionnaires.
• Emergency surgery.
• Refusal to participate or withdrawal of consent.
• Any condition judged by the investigator to interfere with participation or outcome assessment.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara universty

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments were administered by blinded personnel who were not involved in delivering the information sessions.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial Surgery Resident

Model Details: Three-arm, parallel-group randomized study comparing standard counseling alone versus counseling supplemented with a video animation or a 3-D skull model.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)