Ankara universty
Ankara, Turkey (Türkiye)
NCT Number: NCT07394881
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standardized preoperative verbal information provided to all participants.
Standardized preoperative verbal counseling supplemented with an animation video explaining the surgical procedure and potential complications.
Standardized preoperative verbal counseling supplemented with a 3-D anatomical skull model demonstration to explain surgical anatomy and the planned procedure.
Time frame: 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).
Time frame: 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)
Ankara University
Other
Do Video Animations and 3-D Skull Models Reduce Preoperative Anxiety in Bimaxillary Orthognathic Surgery Patients? Single Blinded Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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