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

NCT07439679 | Recruiting

• 1 other identifier: Medipol-OMFS-1997-01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dentofacial Deformities

Keywords

orthognathic surgery; preoperative anxiety; facial edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Postoperative Pain (VAS)

  Postoperative 1 hour to 1 month

• Maximum Mouth Opening (Trismus)

  Postoperative 1 hour to 1 month

• Systolic Blood Pressure

  Intraoperative period

• Diastolic Blood Pressure

  Intraoperative period (from induction of anesthesia to completion of surgery)

• Mean Arterial Pressure

  Intraoperative period (from induction of anesthesia to completion of surgery)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tuba Develi, Dr

  Medipol University

  STUDY CHAIR

Central Study Contacts

Merve Gaye Akgök, DDS

CONTACT

+905064571329; merve.akgok@std.medipol.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, DDS

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

TU (1)