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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Anxiety Group | Participants with STAI-I score ≤36 undergoing bimaxillary orthognathic surgery. | ||
| High Anxiety Group | Participants with STAI-I score ≥46 undergoing bimaxillary orthognathic surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative 1 hour to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain (VAS) | Pain intensity assessed using a Visual Analog Scale (VAS). | Postoperative 1 hour to 1 month |
| Maximum Mouth Opening (Trismus) | Maximum interincisal distance measured in millimeters to evaluate trismus. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing bimaxillary orthognathic surgery for correction of dentofacial deformities at Istanbul Medipol University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merve Gaye Akgök, DDS | Contact | +905064571329 | merve.akgok@std.medipol.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Tuba Develi, Dr | Medipol University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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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| ID | Term |
|---|---|
| D063169 | Dentofacial Deformities |
| ID | Term |
|---|---|
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
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| Postoperative 1 hour to 1 month |
| Systolic Blood Pressure | Intraoperative systolic blood pressure measured in mmHg. | Intraoperative period |
| Diastolic Blood Pressure | Intraoperative diastolic blood pressure measured in millimeters of mercury (mmHg) during orthognathic surgery under general anesthesia. | 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. | 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. | 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. | Intraoperative period (from induction of anesthesia to completion of surgery) |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |