Pre-surgery anxiety and its effects on heart rate, blood pressure, pain, swelling, and mouth opening after orthognathic (jaw) 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
Run by Istanbul Medipol University Hospital · NCT07439679 · Data updated 2026-11-12
This will see if higher anxiety before bimaxillary orthognathic surgery leads to bigger changes in heart rate and blood pressure during the operation and to more pain, facial swelling, or limited mouth opening afterward.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Istanbul Medipol University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07439679 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with dentofacial deformities scheduled for bimaxillary orthognathic surgery who are ASA I or II, able to complete the STAI questionnaire, non-pregnant, non-smokers, and without major systemic or psychiatric conditions are ideal candidates.
✕Probably not a fit
Patients with prior orthognathic surgery, head/neck radiation, active smoking or substance abuse, chronic systemic diseases affecting healing, psychiatric disorders, pregnancy, or inability to attend follow-up visits are excluded and unlikely to benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study at Istanbul Medipol University including patients undergoing bimaxillary orthognathic surgery (Le Fort I plus bilateral sagittal split osteotomy). Preoperative anxiety is measured with the State-Trait Anxiety Inventory (STAI-I and STAI-II) and patients are grouped by STAI-I score. Intraoperative hemodynamic parameters (systolic, diastolic, mean arterial pressure, heart rate, and SpO2) are recorded at predefined time points. Postoperative outcomes—three-dimensional facial edema measurements, pain via Visual Analog Scale (VAS), and maximum mouth opening—are collected at 1 hour, 1 day, 2 days, 5 days, 10 days, and 1 month after surgery.
Why it matters
Potential benefit: If a clear link is found, clinicians could identify anxious patients before surgery and offer targeted interventions to reduce intraoperative instability and improve postoperative pain, swelling, and jaw opening.
How similar studies have gone: Previous work in other surgical fields has linked higher preoperative anxiety to intraoperative hemodynamic changes and worse postoperative pain or swelling, though focused data in bimaxillary orthognathic surgery are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Istanbul Medipol University Hospital
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Merve Gaye Akgök, DDS
- Email: merve.akgok@std.medipol.edu.tr
- Phone: +905064571329
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.