Effect of Audiovisual Versus Verbal Preoperative Information on Dental Anxiety and Hemodynamic Parameters in Patients Undergoing Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- State Anxiety Level (STAI-S)
研究概览
简要总结
This study evaluates whether audiovisual (video-based) or verbal preoperative information is more effective in reducing dental anxiety and stabilizing physiological responses in patients undergoing impacted mandibular third molar surgery.
A total of 73 patients scheduled for third molar extraction were randomly assigned to receive either video-based information or standard verbal information before surgery. Anxiety levels were assessed using validated scales, and physiological parameters such as heart rate, blood pressure, and oxygen saturation were recorded at different stages of the surgical procedure.
The aim of this study is to determine whether the method of preoperative information has an effect on patients' anxiety levels and physiological stress responses during oral surgery.
详细描述
This prospective randomized controlled clinical trial was conducted to evaluate the effects of audiovisual and verbal preoperative information on dental anxiety and hemodynamic parameters in patients undergoing impacted mandibular third molar surgery.
A total of 73 patients scheduled for impacted mandibular third molar extraction were included in the study and randomly assigned to one of two groups: an audiovisual information group (video-based information) and a verbal information group. The audiovisual group received a standardized video presentation explaining the surgical procedure, while the control group received standardized verbal information from the clinician.
Dental anxiety levels were assessed using validated psychometric scales, including the Modified Dental Anxiety Scale (MDAS) and the State-Trait Anxiety Inventory (STAI-S and STAI-T). In addition, physiological parameters such as heart rate, systolic and diastolic blood pressure, and oxygen saturation were recorded at standardized stages of the surgical procedure, including preoperative baseline, anesthesia administration, incision, tooth extraction, suturing, and postoperative period.
The primary objective of the study was to compare the effects of audiovisual and verbal information on dental anxiety levels. Secondary outcomes included the evaluation of hemodynamic parameters during different surgical stages. The study also explored the influence of demographic factors such as age and sex on anxiety and physiological responses.
This study was approved by the Ethics Committee of Gazi University (Decision No: E-77082166-302.08.01-848588), and all participants provided written informed consent prior to inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The surgeon performing the procedure and the investigator recording the data were blinded to group allocation. Participants were aware of the type of preoperative information they received.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for impacted mandibular third molar extraction
- •Age between 18 and 50 years
- •Literate individuals
- •Mentally healthy individuals
- •Individuals without systemic disease
- •Willingness to participate voluntarily and provide written informed consent
排除标准
- •Age under 18 years
- •Illiterate individuals
- •Individuals with psychiatric disorders
- •Individuals who declined to participate
研究组 & 干预措施
Audiovisual Information Group
Participants received a standardized video-based audiovisual explanation of the surgical procedure before the operation.
干预措施: Audiovisual Information (Behavioral)
Verbal Information Group
Standardized verbal information about the surgical procedure was provided to participants by the clinician before surgery.
干预措施: Verbal Information (Behavioral)
结局指标
主要结局
State Anxiety Level (STAI-S)
时间窗: Baseline (preoperative) and immediately after surgery
State anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S), a validated 20-item questionnaire with scores ranging from 20 to 80, where higher scores indicate greater anxiety (worse outcome). Measurements were performed at baseline (preoperative) and after the intervention (preoperative, following audiovisual or verbal information.
Dental Anxiety Level (MDAS)
时间窗: Baseline (preoperative) and immediately postoperatively
Dental anxiety was assessed using the Modified Dental Anxiety Scale (MDAS), a validated 5-item questionnaire with scores ranging from 5 to 25, where higher scores indicate greater dental anxiety (worse outcome). Measurements were performed at baseline (preoperative) and immediately postoperatively.
次要结局
- Heart Rate(During the perioperative period (from baseline to immediately postoperatively))
- Blood Pressure(During the perioperative period (from baseline to immediately postoperatively))
- Oxygen Saturation(During the perioperative period (from baseline to immediately postoperatively))
研究者
Gökhan Hakkı ALPASLAN
Professor of Oral and Maxillofacial Surgery
Gazi University