NCT07439679 Preoperative Anxiety and Its Impact on Intraoperative Hemodynamics and Postoperative Pain, Edema, and Trismus in Orthognathic Surgery
| NCT ID | NCT07439679 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul Medipol University Hospital |
| Condition | Dentofacial Deformities |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2025-02-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Tuba Develi, Dr
STUDY CHAIR
Medipol University
Frequently Asked Questions
Who can join the NCT07439679 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dentofacial Deformities. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07439679 currently recruiting?
Yes, NCT07439679 is actively recruiting participants. Contact the research team at merve.akgok@std.medipol.edu.tr for enrollment information.
Where is the NCT07439679 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07439679 clinical trial?
NCT07439679 is sponsored by Istanbul Medipol University Hospital. The principal investigator is Tuba Develi, Dr at Medipol University. The trial plans to enroll 45 participants.