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临床试验/NCT04017689
NCT04017689Unknown不适用

THE ASSESSMENT OF THE EFFECTS OF DIFFERENT INFORMATION TECHNIQUES ON PATIENTS ANXIETY LEVELS IN IMPLANT SURGERY

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Visual analog scale (VAS) for pain

研究概览

简要总结

The aim of this study is to evaluate the effects of preoperative and postoperative anxiety levels on patients using oral information, visual information with surgical photographs and visual information via audio-video. To evaluate anxiety levels, dental anxiety scale (DAS), modified dental anxiety scale (MDAS) and state anxiety scale (STAI-S, STAI-T) scales will be used.

详细描述

After giving written information about the study, an informed consent form will be distributed to patients who want to participate in the study and they will be asked to sign it. Patients who have signed the consent form will be asked to complete the DAS, MDAS, STAI-T and STAI-S questionnaires in the waiting room to assess preoperative anxiety levels.

Verbal, photos and video information used to inform patients. Patients will be randomly divided into 3 groups. A total of 60 patients with 20 patients in each group will be included in the study. Patients in all groups will be operated by the same surgeon. Oral information will be given to the patients in the first group. In the second group, visual information will be given to the patients by showing the photos of the operation process. Patients in group 3 will also be shown a video of an audio implant operation showing the operation process. The operation video of a previously implanted patient will be watched by the attending physician. This video will begin with the physician informing the patient about the implant and continue with anesthesia. Afterward, the video will be terminated by giving information about the implant operation video and the complications that the patient may encounter and the points to be considered after the operation.

A 7-day pain score will be obtained using the Smiley VAS scale to measure postoperative pain levels and patients will be asked to note how many painkillers they use. In addition, blood pressure and pulse measurements will be taken before and after surgery.

A common text was prepared in all groups in order to provide preoperative information in an ideal way. In group 1, information related to this text will be given orally. In the 2nd and 3rd groups, patients will be informed about the same information as well as visuality.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to the investigator's clinic for implant surgery

排除标准

  • pregnant patients
  • patients using psychiatric drugs
  • patients with visual problems

结局指标

主要结局

Visual analog scale (VAS) for pain

时间窗: immediatly postoperative and postoperative 7th day

scale to find pain amount , pain scores from 0 to 10 will be taken from patients and higher scores indicate worse pain

anxiety scores

时间窗: before instruct about surgery and after instruct about surgery and postoperative 7th day

State-Trait Anxiety Inventory (STAI) scale for state anxiety inculude 20 question trait anxiety and 20 question state anxiety.each question has a point value (1 to 5) and higher point indicate worse anxiety

dental anxiety scores

时间窗: before instruct about surgery and after instruct about surgery and postoperative 7th day

Modified Dental Anxiety Scale (MDAS) for dental anxiety include five question, each questions has a point value (1 to 5) and higher point indicate worse anxiety

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

Funda Bastürk

Master student and research assistant in Oral and Maxillofacial surgery

Necmettin Erbakan University

研究点 (1)

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