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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul Medipol University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

45 Participants
are grouped into 2 trial groups
Group A: Low Anxiety Group
Group B: High Anxiety Group

Trial outcomes

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.

Time frame
Postoperative 1 hour to 1 month

Secondary outcomes

1

Postoperative Pain (VAS)

Pain intensity assessed using a Visual Analog Scale (VAS).

Time frame
Postoperative 1 hour to 1 month
2

Maximum Mouth Opening (Trismus)

Maximum interincisal distance measured in millimeters to evaluate trismus.

Time frame
Postoperative 1 hour to 1 month
3

Systolic Blood Pressure

Intraoperative systolic blood pressure measured in mmHg.

Time frame
Intraoperative period
4

Diastolic Blood Pressure

Intraoperative diastolic blood pressure measured in millimeters of mercury (mmHg) during orthognathic surgery under general anesthesia.

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

Other outcomes

Sponsors and contacts

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