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临床试验/NCT03838081
NCT03838081已完成不适用

Evaluation the Effect of Verbal & Written Information and the Previous Surgical Experience on the Anxiety of Third Molar Extraction

Ankara University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively

研究概览

简要总结

This study was performed on 66 patients who were admitted for third molar extraction under local anesthesia. The patients were divided into three groups: group 1 with verbal information, group 2 with written information, and group 3 with previous surgical experience. Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), and Visual Analog Scale (VAS) were used pre- and postoperatively to evaluate dental anxiety

详细描述

This prospective study included 66 patients who underwent third molar extraction under local anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara University, Turkey, between September and November 2018. The research protocol was approved by the ethical committee of the institute (No: 36290600/69), Ankara University, Turkey.

Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), and Visual Analog Scale (VAS) are commonly used questionnaires for dental anxiety. The latter asked only about age and sex. They were used together before and immediately after surgery to obtain better results in this study.

After examining the panoramic radiographs, patients who underwent extraction were included in Classes 1 and II, Positions A and B according to Pell-Gregory 16 classification, and mesioangular and vertical positions according to the Winter 17 classification.

Each patient was examined by the researcher. The patients were informed about the procedure, and written informed consent was obtained from the patient's preoperative assessment clinic. If a patient had additional questions, they were included as part of the investigation.

The patients were divided into three groups:

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)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-80 years
  • American Society of Anesthesiologists physical status score I and II
  • Patients without any systemic disease, or regular medication use.

排除标准

  • İnability to read and understand Turkish
  • Significantly impaired eyesight or hearing, an existing psychiatric disorder
  • Patients aged less than 18 years

研究组 & 干预措施

Group 1

Experimental

Group 1: Patients who were given only basic information verbally

干预措施: Spielberger State Anxiety Inventory (STAI-S), (Behavioral)

Group 1

Experimental

Group 1: Patients who were given only basic information verbally

干预措施: Dental Fear Scale (DFS) (Behavioral)

Group 1

Experimental

Group 1: Patients who were given only basic information verbally

干预措施: Modified Dental Anxiety Scale (MDAS) (Behavioral)

Group 1

Experimental

Group 1: Patients who were given only basic information verbally

干预措施: Visual Analog Scale (VAS) (Behavioral)

Group 2

Experimental

Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods

干预措施: Spielberger State Anxiety Inventory (STAI-S), (Behavioral)

Group 2

Experimental

Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods

干预措施: Dental Fear Scale (DFS) (Behavioral)

Group 2

Experimental

Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods

干预措施: Modified Dental Anxiety Scale (MDAS) (Behavioral)

Group 2

Experimental

Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods

干预措施: Visual Analog Scale (VAS) (Behavioral)

Group 3

Experimental

Group 3: Patients with previous experience and knowledge about third molar extraction

干预措施: Spielberger State Anxiety Inventory (STAI-S), (Behavioral)

Group 3

Experimental

Group 3: Patients with previous experience and knowledge about third molar extraction

干预措施: Dental Fear Scale (DFS) (Behavioral)

Group 3

Experimental

Group 3: Patients with previous experience and knowledge about third molar extraction

干预措施: Modified Dental Anxiety Scale (MDAS) (Behavioral)

Group 3

Experimental

Group 3: Patients with previous experience and knowledge about third molar extraction

干预措施: Visual Analog Scale (VAS) (Behavioral)

结局指标

主要结局

Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively

时间窗: 2 minutes

Spielberger State Anxiety Inventory (STAI) is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety. The inventory has 2 different scales, each with 20 items, showing the state and trait anxiety levels: STAI-state is used to determine a patient's current anxiety level, and STAI-trait is used to determine a patient's underlying (ongoing/personality) anxiety level. All 20 items are rated on a 4-point scale. The total score obtained can range from 20 to 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). We used only STAI-S

Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively

时间窗: 2 minutes

DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice

Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively

时间窗: 1 minute

MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25

Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively

时间窗: 1 minute

VAS is ideal for evaluating situations that cannot be measured using digital and oral information 25. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable."

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevser Sancak

Oral and Maxillofacial surgery, Principal investigator

Ankara University

研究点 (2)

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