Preoperative Anxiety and Its Impact on Intraoperative Hemodynamics and Postoperative Pain, Edema, and Trismus in Orthognathic Surgery

The Effect of Preoperative Anxiety Levels on Intraoperative Hemodynamic Parameters and Postoperative Edema, Pain, and Trismus in Patients Undergoing Bimaxillary Orthognathic Surgery: A Prospective Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Dentofacial Deformities

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Merve Gaye Akgök, DDS; Phone Number: +905064571329; Email: merve.akgok@std.medipol.edu.tr

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Istanbul Medipol University Hospital
    • Contact: Merve Gaye Akgök, DDS; Phone Number: +905064571329; Email: merve.akgok@std.medipol.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing bimaxillary orthognathic surgery for correction of dentofacial deformities at Istanbul Medipol University.

Description

Inclusion Criteria:

• ASA physical status I or II
• Patients scheduled for bimaxillary orthognathic surgery (Le Fort I osteotomy and bilateral sagittal split ramus osteotomy)
• Ability to understand and complete the STAI questionnaire
• Provision of written informed consent

Exclusion Criteria:

• Previous orthognathic surgery
• History of maxillofacial trauma
• History of radiotherapy or chemotherapy in the head and neck region
• Presence of psychiatric disorders or current use of psychiatric medications
• Chronic systemic disease affecting bone metabolism or wound healing
• Active smoking or substance abuse
• Pregnancy or lactation
• Incomplete questionnaire responses
• Inability to attend follow-up visits

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Chair: Tuba Develi, Dr, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: preoperative anxiety; orthognathic surgery; facial edema
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dentofacial Deformities
• Other Study ID Numbers: Medipol-OMFS-1997-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No