An observational study in Dentofacial Deformities, sponsored by Istanbul Medipol University Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Istanbul Medipol University Hospital · Observational
This study aims to investigate the relationship between preoperative anxiety and intraoperative hemodynamic changes, as well as postoperative pain and facial edema, in patients undergoing orthognathic surgery.
Orthognathic surgery is a corrective jaw surgery performed to treat dentofacial deformities. Although the procedure improves functional and aesthetic outcomes, patients may experience significant anxiety before surgery. Elevated anxiety levels may influence physiological responses during the operation and may affect postoperative recovery.
In this study, preoperative anxiety levels will be evaluated using validated assessment scales prior to surgery. During the intraoperative period, hemodynamic parameters such as heart rate and blood pressure will be recorded. After surgery, postoperative pain and facial edema will be assessed using standardized clinical evaluation methods.
The objective of this research is to determine whether higher levels of preoperative anxiety are associated with changes in intraoperative hemodynamic stability and increased postoperative discomfort. The findings may contribute to improved perioperative management strategies and enhanced patient care in orthognathic surgery.
This prospective, single-center clinical study is being conducted at the Department of Oral and Maxillofacial Surgery, Istanbul Medipol University. The aim of the study is to evaluate the effect of preoperative anxiety levels on intraoperative hemodynamic parameters and postoperative facial edema, pain, and trismus in patients undergoing bimaxillary orthognathic surgery.
Patients classified as ASA I or ASA II and scheduled to undergo Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy are being included in the study. Patients with a history of previous orthognathic surgery, psychiatric disorders, systemic diseases that may affect healing, active smoking, pregnancy, or incomplete questionnaire responses are being excluded.
Preoperative anxiety levels are being assessed using the State-Trait Anxiety Inventory (STAI-I and STAI-II). Based on STAI-I scores, patients are being categorized into low-anxiety and high-anxiety groups.
During the intraoperative period, systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation are being recorded at predefined time intervals.
Postoperative evaluations are being performed at 1 hour, 1 day, 2 days, 5 days, 10 days, and 1 month after surgery. Facial edema is being measured using a three-dimensional digital facial scanning system, pain intensity is being assessed using the Visual Analog Scale (VAS), and maximum mouth opening is being measured to determine the degree of trismus.
39 studies on the registry are indexed under Dentofacial Deformities; 15 are open to participants now.
This study's planned enrollment of 45 is close to the median of 48 across 14 observational studies indexed under Dentofacial Deformities.
Browse Dentofacial Deformities studies →Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing bimaxillary orthognathic surgery for correction of dentofacial deformities at Istanbul Medipol University.
Exclusion Criteria:
Participants with STAI-I score ≤36 undergoing bimaxillary orthognathic surgery.
Participants with STAI-I score ≥46 undergoing bimaxillary orthognathic surgery.
Postoperative Facial Edema
Facial edema measured using a three-dimensional digital facial scanning system at postoperative 1 hour, 1st, 2nd, 5th, and 10th days and 1 month.
Time frame: Postoperative 1 hour to 1 month
Postoperative Pain (VAS)
Pain intensity assessed using a Visual Analog Scale (VAS).
Time frame: Postoperative 1 hour to 1 month
Maximum Mouth Opening (Trismus)
Maximum interincisal distance measured in millimeters to evaluate trismus.
Time frame: Postoperative 1 hour to 1 month
Systolic Blood Pressure
Intraoperative systolic blood pressure measured in mmHg.
Time frame: Intraoperative period
Diastolic Blood Pressure
Intraoperative diastolic blood pressure measured in millimeters of mercury (mmHg) during orthognathic surgery under general anesthesia.
Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)
Mean Arterial Pressure
Mean arterial pressure recorded intraoperatively in millimeters of mercury (mmHg) to assess hemodynamic stability during surgery.
Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)
Heart Rate
Heart rate recorded intraoperatively in beats per minute (bpm) to evaluate cardiovascular response during surgery.
Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)
Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation (SpO2) measured intraoperatively using pulse oximetry to assess oxygenation status.
Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)
Plan to share: Undecided — The decision to share individual participant data (IPD) has not yet been determined. Data sharing may be considered after publication of the primary results and in accordance with institutional policies and ethical approvals.
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Istanbul Medipol University Hospital