NCT07394881

Visual Tools and Preoperative Anxiety in Orthognathic Surgery

Do Video Animations and 3-D Skull Models Reduce Preoperative Anxiety in Bimaxillary Orthognathic Surgery Patients? Single Blinded Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This was a single-center, randomized, parallel-group study assessing the effect of different counseling tools on preoperative anxiety in patients undergoing elective bimaxillary orthognathic surgery. All participants received standardized verbal preoperative information delivered in a consistent setting. Group A received verbal information only; Group B received verbal information supplemented with an animation video; and Group C received verbal information supplemented with a 3-D anatomical skull model demonstration. Information sessions were standardized and lasted approximately 10 minutes. Anxiety was measured using the STAI (state and trait components) and a VAS at two predefined time points: baseline (before the information session) and approximately one hour before surgery. The main comparisons were changes in anxiety scores between groups to evaluate whether visual tools reduced preoperative anxiety beyond standard counseling. Data collection of anxiety assessments was performed by blinded personnel, and ethical approval and written informed consent were obtained.

Conditions

• Preoperative Anxiety
• Orthognathic Surgical Procedures

Interventions

Type	Name	Description
BEHAVIORAL	Verbal İnformation	Standardized preoperative verbal information provided to all participants.
BEHAVIORAL	Animation Video Counseling	Standardized preoperative verbal counseling supplemented with an animation video explaining the surgical procedure and potential complications.
BEHAVIORAL	3-D Skull Model Counseling	Standardized preoperative verbal counseling supplemented with a 3-D anatomical skull model demonstration to explain surgical anatomy and the planned procedure.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2026-02-06
• Last updated: 2026-02-10

Locations

1 site across 1 country: Turkey (Türkiye)