Orthognathic Surgical Procedures, Preoperative Anxiety
Conditions
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.
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.
Interventions
BEHAVIORALVerbal İnformation
Standardized preoperative verbal information provided to all participants.
BEHAVIORALAnimation Video Counseling
Standardized preoperative verbal counseling supplemented with an animation video explaining the surgical procedure and potential complications.
BEHAVIORAL3-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.
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments were administered by blinded personnel who were not involved in delivering the information sessions.
Intervention model description
Three-arm, parallel-group randomized study comparing standard counseling alone versus counseling supplemented with a video animation or a 3-D skull model.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for Anxiety (VAS-A) | From baseline (before preoperative counseling) to immediately before surgery | 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). |
| State-Trait Anxiety Inventory | From baseline (before preoperative counseling) to immediately before surgery | 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) |
Countries
Turkey (Türkiye)
Outcome results
None listed