The Effect of Preoperative Patient Information Strategies on Anxiety and Hemodynamic Responses During Third Molar Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 主要终点
- Change from Baseline in Modified Dental Anxiety Scale (MDAS) Score After Third Molar Surgery
研究概览
简要总结
This randomized clinical trial investigates the effect of different preoperative patient information strategies on anxiety levels and hemodynamic responses during third molar extraction. Ninety-seven patients were assigned to control, verbal information, or visual (animation) information groups. Anxiety was measured using the Modified Dental Anxiety Scale (MDAS) and State-Trait Anxiety Inventory (STAI), while heart rate, blood pressure, oxygen saturation, and pain were recorded. The study aims to assess whether educational interventions can reduce anxiety and improve patient comfort during oral surgery.
详细描述
This prospective, randomized clinical trial was designed to evaluate the effect of different preoperative patient information strategies on anxiety levels, hemodynamic responses, and pain perception during the surgical extraction of impacted mandibular third molars. Third molar extraction is a common procedure in oral and maxillofacial surgery, often associated with elevated patient anxiety, which can negatively affect both psychological well-being and physiological parameters such as heart rate and blood pressure.
In this study, 97 patients requiring surgical removal of a single impacted mandibular third molar were recruited and randomly assigned into one of three groups:
- Control group - provided with a brief, basic explanation of the surgical procedure;
- Verbal information group - provided with a detailed, non-technical verbal explanation covering the anesthesia, surgical steps, and post-operative care;
- Visual information group - provided with the same verbal explanation plus an educational 2D animation illustrating the surgical process.
The anxiety levels of participants were measured using two validated scales: the Modified Dental Anxiety Scale (MDAS) and the State-Trait Anxiety Inventory (STAI), both before and after surgery. Physiological measurements, including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation (SaO₂), were recorded at five standardized time points: before surgery, after information delivery and before anesthesia, after anesthesia, during tooth extraction, and in the postoperative period. Pain levels were assessed during the procedure using a Visual Analog Scale (VAS).
All surgeries were conducted under local anesthesia by experienced oral surgeons, following a standardized surgical protocol to minimize operator-related variability. The study also considered demographic and clinical variables, such as patient age, sex, education level, and the depth of impaction of the third molar, as potential factors influencing anxiety and physiological responses.
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
- None
盲法说明
Due to the nature of the interventions, which involved providing different types of preoperative patient education (basic explanation, detailed verbal explanation, visual animation), masking was not feasible, and both participants and investigators were aware of group assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Requiring surgical removal of a impacted mandibular third molar
- •Ability to read and complete the questionnaires
- •Willingness to participate in the study
排除标准
- •Age < 18 years
- •History of systemic disease contraindicating surgery
- •Poor oral hygiene
- •Current pericoronitis or acute infection around the third molar
- •Pregnancy
研究组 & 干预措施
Control Group
Participants receive only a basic, brief explanation of the surgical procedure without additional detailed verbal or visual information.
干预措施: Basic Preoperative Information (Other)
Control Group
Participants receive only a basic, brief explanation of the surgical procedure without additional detailed verbal or visual information.
干预措施: Surgical extraction of impacted mandibular third molar (Procedure)
Control Group
Participants receive only a basic, brief explanation of the surgical procedure without additional detailed verbal or visual information.
干预措施: Multiparameter patient monitor (Device)
Verbal Information Group
Participants receive a comprehensive verbal explanation of the surgical procedure, covering all key steps such as anesthesia, incision, bone removal, tooth sectioning, and suturing, delivered in clear, non-technical language to optimize patient understanding.
干预措施: Detailed Verbal Preoperative Information (Other)
Verbal Information Group
Participants receive a comprehensive verbal explanation of the surgical procedure, covering all key steps such as anesthesia, incision, bone removal, tooth sectioning, and suturing, delivered in clear, non-technical language to optimize patient understanding.
干预措施: Surgical extraction of impacted mandibular third molar (Procedure)
Verbal Information Group
Participants receive a comprehensive verbal explanation of the surgical procedure, covering all key steps such as anesthesia, incision, bone removal, tooth sectioning, and suturing, delivered in clear, non-technical language to optimize patient understanding.
干预措施: Multiparameter patient monitor (Device)
Visual Information Group
Participants receive the same detailed verbal explanation as the verbal information group, supplemented with a 2D animated video illustrating the surgical procedure
干预措施: Visual Preoperative Information (2D Animation) (Other)
Visual Information Group
Participants receive the same detailed verbal explanation as the verbal information group, supplemented with a 2D animated video illustrating the surgical procedure
干预措施: Surgical extraction of impacted mandibular third molar (Procedure)
Visual Information Group
Participants receive the same detailed verbal explanation as the verbal information group, supplemented with a 2D animated video illustrating the surgical procedure
干预措施: Multiparameter patient monitor (Device)
结局指标
主要结局
Change from Baseline in Modified Dental Anxiety Scale (MDAS) Score After Third Molar Surgery
时间窗: From baseline (before patient education) to within 1 hour after completion of third molar extraction
The Modified Dental Anxiety Scale (MDAS) is a validated questionnaire consisting of 5 items, each scored from 1 (not anxious) to 5 (extremely anxious), producing a total score range of 5 to 25. Higher scores indicate higher levels of dental anxiety. In this study, participants completed the MDAS before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in MDAS score from baseline to postoperative was calculated to assess the effect of patient education interventions on dental anxiety levels.
Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-Trait) Score After Third Molar Surgery
时间窗: From baseline (before patient education) to within 1 hour after completion of third molar extraction
The Spielberger State-Trait Anxiety Inventory - Trait (STAI-T) subscale is a validated self-reported questionnaire with 20 items, each rated from 1 (almost never) to 4 (almost always), giving a total score between 20 and 80. Higher scores indicate higher levels of trait anxiety. In this study, participants completed the STAI-T before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in STAI-Trait score from baseline to postoperative was calculated to assess the effect of patient education on trait anxiety.
Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-State) Score After Third Molar Surgery
时间窗: From baseline (before patient education) to within 1 hour after completion of third molar extraction
The Spielberger State-Trait Anxiety Inventory - State (STAI-S) subscale is a validated self-reported questionnaire with 20 items, each rated from 1 (not at all) to 4 (very much so), giving a total score between 20 and 80. Higher scores indicate higher levels of state anxiety. In this study, participants completed the STAI-S before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in STAI-State score from baseline to postoperative was calculated to assess the effect of patient education on state anxiety.
次要结局
- Change in Heart Rate (HR) During Third Molar Surgery(From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes))
- Change in Systolic Blood Pressure (SBP) During Third Molar Surgery(From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes))
- Change in Diastolic Blood Pressure (DBP) During Third Molar Surgery(From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes))
- Change in Peripheral Oxygen Saturation (SpO₂) During Third Molar Surgery(From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes))
- Pain Intensity During Tooth Extraction Measured by Visual Analog Scale (VAS)(From the start of tooth elevation to immediately after tooth removal (approximately minutes 15 to 20 of the procedure))
- Duration of Third Molar Extraction Procedure(From the first surgical incision to the final suture placement (approximately 10 to 30 minutes total))
研究者
Ummugulsum Coskun
Assistant Professor of Oral and Maxillofacial Surgery, DDS, PhD
Altinbas University