Actively Recruiting

Age: 18Years +
All Genders
ID07439679

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

Led by Istanbul Medipol University Hospital · Updated on 2026-02-27

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how preoperative anxiety affects patients undergoing bimaxillary orthognathic surgery, a corrective jaw surgery for dentofacial deformities. The study aims to understand if anxiety before surgery influences changes in heart rate and blood pressure during the operation, as well as pain, facial swelling, and limited mouth opening after surgery. This observational study is conducted at Istanbul Medipol University Hospital and focuses on patients classified as ASA I or II. Participants are evaluated for anxiety using the State-Trait Anxiety Inventory before surgery and grouped into low or high anxiety categories based on their scores. During surgery, vital signs such as systolic and diastolic blood pressure, mean arterial pressure, heart rate, and oxygen saturation are closely monitored. After surgery, follow-up assessments take place at several time points from 1 hour to 1 month, measuring facial swelling with 3D scanning, pain levels using a visual scale, and mouth opening to assess trismus. Throughout the study, patients complete anxiety questionnaires and attend multiple postoperative visits for detailed evaluations. Researchers analyze the collected data to find connections between anxiety levels and physiological changes during and after surgery. The main outcome is the measurement of facial swelling after surgery, with additional focus on pain, mouth opening, and intraoperative vital signs. The study helps improve understanding of how anxiety may affect recovery and care in orthognathic surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status I or II
  • Scheduled for bimaxillary orthognathic surgery including Le Fort I osteotomy and bilateral sagittal split ramus osteotomy
  • Ability to understand and complete the State-Trait Anxiety Inventory questionnaire
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo bimaxillary orthognathic surgery including Le Fort I osteotomy and bilateral sagittal split ramus osteotomy. Intraoperative monitoring of blood pressure, heart rate, and oxygen saturation is conducted.

1 visit (in-person)

Post-operative Follow-up

Duration - 1 hour to 1 month after surgery

Participants are evaluated for facial edema, pain intensity, and mouth opening (trismus) after surgery.

6 visits (postoperative at 1 hour, 1 day, 2 days, 5 days, 10 days, and 1 month)

Trial Site Locations

Total: 1 location

1

Istanbul Medipol University Hospital

Istanbul, Turkey (Türkiye)

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Research Team

M

Merve Gaye Akgök, DDS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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