- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484334
Effect of Preoperative Information Videos on Anxiety and Vital Signs in Impacted Third Molar Surgery
The Effect of Preoperative Surgical Information Videos on Hemodynamic Parameters and Dental Anxiety in Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
Study Overview
Status
Detailed Description
Impacted mandibular third molar surgery is a common oral surgical procedure that is frequently associated with patient stress, fear, and physiologic fluctuations during the perioperative period. In addition to subjective anxiety, these stress responses may be reflected in hemodynamic parameters such as systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation.
This randomized controlled study was designed to investigate whether physician-guided visual information can improve perioperative hemodynamic stability compared with standard verbal information alone. Participants undergoing impacted mandibular third molar surgery are assigned to one of three preoperative information approaches: standard verbal information, real surgical video information, or 3D animation video information.
The primary objective is to compare the effects of these information modalities on perioperative hemodynamic responses measured at predefined time points, including baseline, after local anesthesia, during tooth luxation, after suturing, and during the early recovery period. The secondary objective is to evaluate the effect of these information methods on dental fear using a validated psychometric scale.
The study is based on the hypothesis that visually supported preoperative information, when delivered in a structured and physician-guided manner, may reduce stress-related physiologic fluctuations during surgery and may also influence patients' self-reported dental fear. By comparing verbal, real video, and animation-based information methods, the study aims to clarify whether visual information contributes to better physiologic regulation and patient preparation before third molar surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Rize, Merkez, Turkey (Türkiye), 53200
- Recep Tayyip Erdogan University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 50 years
- ASA physical status I or II
- Radiographic evidence of an impacted mandibular third molar classified as Pell-Gregory Class I or II and Position A or B
- Presence of mandibular third molar (tooth 38 or 48) in a vertical or mesioangular position according to Winter's classification
- Indication for impacted mandibular third molar extraction
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Active smoking or alcohol consumption
- Bleeding/coagulation disorders or any systemic disease/medication use that could impair wound healing
- Pregnancy or lactation
- Local pathologies associated with the impacted tooth, such as cysts or tumors
- History of severe anxiety disorder or known psychiatric illness
- Known allergy to local anesthetics or planned postoperative medications
- Presence of uncontrolled active periodontal disease
- Inability or unwillingness to comply with follow-up procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Verbal Information
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
|
Experimental: Real Surgical Video Information
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
|
Experimental: 3D Animation Video Information
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
Time Frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
|
Systolic blood pressure is measured in millimeters of mercury (mmHg) to evaluate hemodynamic stability.
The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
|
Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
|
|
Change in Diastolic Blood Pressure (DBP)
Time Frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
|
Diastolic blood pressure is measured in millimeters of mercury (mmHg) to evaluate hemodynamic stability.
The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
|
Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
|
|
Change in Heart Rate (HR)
Time Frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
|
Heart rate is measured in beats per minute (bpm) to evaluate physiological stress response.
The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
|
Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
|
|
Change in Oxygen Saturation (SpO₂)
Time Frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
|
Peripheral oxygen saturation is measured as a percentage (%) to evaluate respiratory stability.
The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4)
|
Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Dental Fear Survey (MDFS) Score
Time Frame: Assessed once, immediately after the preoperative information intervention (just prior to surgery)
|
Dental fear is assessed using the Modified Dental Fear Survey (MDFS).
The survey consists of 20 items, with each item scored on a 5-point Likert scale (from 1 = not at all, to 5 = very much).
The total score ranges from a minimum of 20 to a maximum of 100.
Higher scores indicate a higher level of dental fear and anxiety, which represents a worse outcome.
|
Assessed once, immediately after the preoperative information intervention (just prior to surgery)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1462 (CSL Behring)
- 2025/225 (Other Identifier: Non-Interventional Clinical Research Ethics Committee of Recep Tayyip Erdoğan University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Anxiety
-
Aga Khan University Hospital, PakistanDow University of Health Sciences; Civil Hospital KarachiCompletedDental Anxiety | Dental Fear and AnxietyPakistan
-
Riham AbbasRecruitingDental Anxiety | Dental Fear | Dental Fear and AnxietyEgypt
-
Universidade Federal do Rio Grande do NorteCompletedDental Anxiety | Dental Fear and AnxietyBrazil
-
University of PaviaCompletedDental Anxiety | Dental PhobiaItaly
-
Cairo UniversityUnknownAnxiety, Dental | Fear, Dental
-
St. Justine's HospitalRecruitingDental Anxiety | Dental Trauma | Dental Diseases | Dental PhobiaCanada
-
St. Justine's HospitalCompletedDental Anxiety | Dental Trauma | Dental Diseases | Dental PhobiaCanada
-
Alexandria UniversityNot yet recruitingPediatric Dental Anxiety | Pediatric Dental PainEgypt
-
Ataturk UniversityScientific Research Projects Coordınatıon Unit of Atatürk UniversityRecruiting
-
Selcuk UniversityCompleted
Clinical Trials on Standard Verbal Information
-
Mehmet Burak EşkinRecruitingPediatric Preoperative AnxietyTurkey (Türkiye)
-
Mid Western Regional Hospital, IrelandCompleted
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedHealth CommunicationNorway
-
Gazi UniversityCompletedDental Anxiety | Impacted Mandibular Third MolarTurkey (Türkiye)
-
Parc de Salut MarCompletedTotal Knee ReplacementSpain
-
Universidad Autonoma de Nuevo LeonCompletedOsteoarthritis | RehabilitationMexico
-
Elazıg Fethi Sekin Sehir HastanesiNot yet recruitingCesarean Section | Preoperative Anxiety | Cortisol | Surgical Stress Response
-
Brigham and Women's HospitalCompletedHeart Failure | Quality of LifeUnited States
-
Medical College of WisconsinCompletedPremature BirthUnited States
-
Universitaire Ziekenhuizen KU LeuvenRecruitingSkin Cancer | Management | Low RiskBelgium