Dentofacial DeformitiesNCT07439679
Preoperative Anxiety and Its Impact on Intraoperative Hemodynamics and Postoperative Pain, Edema, and Trismus in Orthognathic Surgery
An observational study of Dentofacial Deformities, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dentofacial Deformities
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing bimaxillary orthognathic surgery for correction of dentofacial deformities at Istanbul Medipol University.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy or lactation
- Incomplete questionnaire responses
- Inability to attend follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University Hospital
Istanbul
Merve Gaye Akgök, DDS, +905064571329, merve.akgok@std.medipol.edu.tr
About this study
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
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.
Read more
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.
Read the detailed description
This prospective, single-center clinical study is being conducted at the Department of Oral and Maxillofacial Surgery, Istanbul Medipol University. The aim of the study is to evaluate the effect of preoperative anxiety levels on intraoperative hemodynamic parameters and postoperative facial edema, pain, and trismus in patients undergoing bimaxillary orthognathic surgery.
Patients classified as ASA I or ASA II and scheduled to undergo Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy are being included in the study. Patients with a history of previous orthognathic surgery, psychiatric disorders, systemic diseases that may affect healing, active smoking, pregnancy, or incomplete questionnaire responses are being excluded.
Preoperative anxiety levels are being assessed using the State-Trait Anxiety Inventory (STAI-I and STAI-II). Based on STAI-I scores, patients are being categorized into low-anxiety and high-anxiety groups.
During the intraoperative period, systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation are being recorded at predefined time intervals.
Postoperative evaluations are being performed at 1 hour, 1 day, 2 days, 5 days, 10 days, and 1 month after surgery. Facial edema is being measured using a three-dimensional digital facial scanning system, pain intensity is being assessed using the Visual Analog Scale (VAS), and maximum mouth opening is being measured to determine the degree of trismus.
- Conditions
- Dentofacial Deformities
- Keywords
- orthognathic surgery, preoperative anxiety, facial edema
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 1 hour to 1 month
Secondary outcomes (7)
Postoperative Pain (VAS)
Pain intensity assessed using a Visual Analog Scale (VAS).
Measured: Postoperative 1 hour to 1 month
Maximum Mouth Opening (Trismus)
Maximum interincisal distance measured in millimeters to evaluate trismus.
Measured: Postoperative 1 hour to 1 month
Systolic Blood Pressure
Intraoperative systolic blood pressure measured in mmHg.
Measured: Intraoperative period
Diastolic Blood Pressure
Intraoperative diastolic blood pressure measured in millimeters of mercury (mmHg) during orthognathic surgery under general anesthesia.
Measured: Intraoperative period (from induction of anesthesia to completion of surgery)
Mean Arterial Pressure
Mean arterial pressure recorded intraoperatively in millimeters of mercury (mmHg) to assess hemodynamic stability during surgery.
Measured: Intraoperative period (from induction of anesthesia to completion of surgery)
Heart Rate
Heart rate recorded intraoperatively in beats per minute (bpm) to evaluate cardiovascular response during surgery.
Measured: Intraoperative period (from induction of anesthesia to completion of surgery)
Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation (SpO2) measured intraoperatively using pulse oximetry to assess oxygenation status.
Measured: Intraoperative period (from induction of anesthesia to completion of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gaye Akgök, Istanbul Medipol University Hospital
- Investigators
- Tuba Develi, Dr, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439679
- Sponsor's protocol ID
- Medipol-OMFS-1997-01
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not yet been determined. Data sharing may be considered after publication of the primary results and in accordance with institutional policies and ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07439679
- Acronym / sponsor ID
- Medipol-OMFS-1997-01
- Conditions
- Dentofacial Deformities
- Keywords
- orthognathic surgery, preoperative anxiety, facial edema
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, single-center clinical study is being conducted at the Department of Oral and Maxillofacial Surgery, Istanbul Medipol University. The aim of the study is to evaluate the effect of preoperative anxiety levels on intraoperative hemodynamic parameters and postoperative facial edema, pain, and trismus in patients undergoing bimaxillary orthognathic surgery.
Patients classified as ASA I or ASA II and scheduled to undergo Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy are being included in the study. Patients with a history of previous orthognathic surgery, psychiatric disorders, systemic diseases that may affect healing, active smoking, pregnancy, or incomplete questionnaire responses are being excluded.
Preoperative anxiety levels are being assessed using the State-Trait Anxiety Inventory (STAI-I and STAI-II). Based on STAI-I scores, patients are being categorized into low-anxiety and high-anxiety groups.
During the intraoperative period, systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation are being recorded at predefined time intervals.
Postoperative evaluations are being performed at 1 hour, 1 day, 2 days, 5 days, 10 days, and 1 month after surgery. Facial edema is being measured using a three-dimensional digital facial scanning system, pain intensity is being assessed using the Visual Analog Scale (VAS), and maximum mouth opening is being measured to determine the degree of trismus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing bimaxillary orthognathic surgery for correction of dentofacial deformities at Istanbul Medipol University.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Facial Edema
Time frame: Postoperative 1 hour to 1 month
Facial edema measured using a three-dimensional digital facial scanning system at postoperative 1 hour, 1st, 2nd, 5th, and 10th days and 1 month.
7 secondary outcomes
Postoperative Pain (VAS)
Time frame: Postoperative 1 hour to 1 month
Maximum Mouth Opening (Trismus)
Time frame: Postoperative 1 hour to 1 month
Systolic Blood Pressure
Time frame: Intraoperative period
Diastolic Blood Pressure
Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)
Mean Arterial Pressure
Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)
Heart Rate
Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)
Peripheral Oxygen Saturation (SpO2)
Time frame: Intraoperative period (from induction of anesthesia to completion of surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not yet been determined. Data sharing may be considered after publication of the primary results and in accordance with institutional policies and ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuba Develi, Dr study chair
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentofacial Deformities, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Gaye Akgök, DDS (+905064571329, merve.akgok@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Facial Edema (time frame: Postoperative 1 hour to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.