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临床试验/NCT04613947
NCT04613947已完成不适用

Investigation of the Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated with Third Molar Surgery

T.C. ORDU ÜNİVERSİTESİ2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Dental anxiety

研究概览

简要总结

The aim of this study is to investigate the effect of information provided in accordance with intelligence type on anxiety associated with wisdom tooth surgery.

详细描述

The participants who will undergo third molar surgery divided into study and control groups. Study group divided further into three groups according to multiple intellegence test. Ultimately four groups created as follows;

  1. Control: The group with standard (written and verbal) information without multiple intelligence test
  2. Visual/Spatial: The group with higher visual intelligence according to the multiple intelligence test results and watch video. Also, will given with a written informed consent document.
  3. Verbal/Linguistic: The group with higher verbal/linguistic intelligence according to the multiple intelligence test results and verbally informed in detail about the operation. lso, will given with a written informed consent document
  4. Bodily/Kinesthetic: The group with higher bodily/kinesthetic intelligence according to the multiple intelligence test results and informed with a dental model. lso, will given with a written informed consent document To evaluate anxiety; participants will asked to complete MDAS questionnairre before and after consent, and after operation. Also, saliva samples will obtained to evaluate the salivary cortisol before and after consent, and after operation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mandibular third molar tooth in vertical or mesioangular position according to Winter classification, class I and II ramus relationship according to Pell-Gregory classification and class B and C depth
  • Patients who maintain their normal sleep patterns,
  • Patients with ASA I status according to the American Society of Anesthesiologists (ASA) classification.

排除标准

  • Patients did not agree to be a volunteer, and/or refused to watch videos or receive information in a different way from the standard procedure,
  • Habits of Smoking and alcohol
  • Patients who are pregnant or in the lactation period,
  • Patients unable to cooperate,
  • Patients having a psychiatric illness,
  • Patients with systemic disease (local or systemic factors affecting salivary gland function, can cause changes in endocrine response)
  • Patients using chronic medication and drugs that affect salivary cortisol levels, such as androgens, estrogens and corticosteroids.
  • Patients with pericoronitis

结局指标

主要结局

Dental anxiety

时间窗: at operation day (before and after operation and immediately after consent)

Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS) MDAS consists of five questions in total which measures anxiety at different stages of dental treatment. 1 (no anxious) to 5 (very anxious) options are available for each question. The sum of the scores varies from 5 to 25 and the values between 19-25 indicates high dental anxiety.

次要结局

  • Salivary cortisol level(at operation day (before and after operation and immediately after consent))

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Damla Torul

Assistant Professor

T.C. ORDU ÜNİVERSİTESİ

研究点 (2)

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