Clinician-Guided Preoperative Information Formats and Perioperative Physiological Responses in Impacted Mandibular Third Molar Surgery: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure (SBP)
研究概览
简要总结
This study evaluates whether physician-guided visual information provided before impacted mandibular third molar surgery can improve hemodynamic stability during the perioperative period. Participants are assigned to one of three preoperative information methods: standard verbal information, real surgical video information, or 3D animation video information. Changes in systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation are assessed at multiple perioperative time points to determine whether visual information reduces stress-related physiologic responses. The study also examines whether these information methods influence preoperative dental fear.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The operating clinician/investigator was blinded to group assignment during the surgical procedure. Participants were aware of the type of preoperative information they received; therefore, participant masking was not possible.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard Verbal Information
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
干预措施: Standard Verbal Information (Behavioral)
Real Surgical Video Information
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
干预措施: Real Surgical Video Information (Behavioral)
3D Animation Video Information
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
干预措施: 3D Animation Video Information (Behavioral)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP)
时间窗: 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).
Change in Diastolic Blood Pressure (DBP)
时间窗: 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).
Change in Heart Rate (HR)
时间窗: 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).
Change in Oxygen Saturation (SpO₂)
时间窗: 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)
Change in Systolic Blood Pressure (SBP)
时间窗: Preoperative, intraoperative, and 15 minutes postoperatively
Systolic blood pressure measured at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Change in Diastolic Blood Pressure (DBP)
时间窗: Preoperative, during surgery, and 15 minutes after surgery
Diastolic blood pressure measured at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Change in Heart Rate (HR)
时间窗: Preoperative, during surgery, and 15 minutes after surgery
Heart rate measured at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Change in Oxygen Saturation (SpO₂)
时间窗: Preoperative, intraoperative, and 15 minutes postoperatively
Peripheral oxygen saturation measured at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
次要结局
- Modified Dental Fear Survey (MDFS) Score(Assessed once, immediately after the preoperative information intervention (just prior to surgery))
- Modified Dental Fear Survey (MDFS) Score(Immediately after preoperative information, before surgery)
研究者
Emre Can ÇIRALIK
Research Assistant, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry
Recep Tayyip Erdogan University