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

Official title

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

Overview

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.

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.

Primary outcome measures

• Postoperative Facial Edema [Time frame: Postoperative 1 hour to 1 month]

Secondary outcome measures (7)

• Postoperative Pain (VAS) [Time frame: Postoperative 1 hour to 1 month]
• Maximum Mouth Opening (Trismus) [Time frame: Postoperative 1 hour to 1 month]
• Systolic Blood Pressure [Time frame: Intraoperative period]
• Diastolic Blood Pressure [Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)]
• Mean Arterial Pressure [Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)]
• Heart Rate [Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)]
• Peripheral Oxygen Saturation (SpO2) [Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Istanbul Medipol University Hospital — Istanbul

Identifiers

NCT: NCT07439679 · Medipol-OMFS-1997-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗