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临床试验/NCT06150911
NCT06150911招募中不适用

A Study of Pain, Anxiety, and Impacts on Oral Health-related Quality of Life(OHRQoL) for Patients Before, During and After Orthodontic Treatment

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Visual Analogue Scale(VAS) pain scale

研究概览

简要总结

The goal of this observational study is to learn about pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment. The recruited participants with good health are from Kaohsiung medical university and local dental clinics .

The main questions it aims to answer are:

  1. The differences of pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment.
  2. The correlation of pain, anxiety and oral health-related quality of life in our participant
  3. The differences of seven domain in OHIP-14 scale in our participants The participants are asked to complete a self-administered in different time point.

详细描述

Orthodontic treatment is a common dental procedure aimed at improving teeth and bite alignment issues. Patients may experience various challenges before, during, and after orthodontic treatment, including pain, anxiety, and the impact on oral health-related quality of life. Here are some aspects to consider in researching these areas:

Pain: Orthodontic treatment typically causes a certain level of discomfort and pain. Research can focus on assessing changes in the intensity and frequency of pain experienced by patients before, during, and after treatment. Pain can be evaluated using visual analog scales or numerical rating scales, and the duration and relief of pain should be tracked.

Anxiety: Orthodontic treatment may induce anxiety and stress in some patients. Studies can assess anxiety levels at different stages of treatment through surveys or psychological measurement tools like anxiety assessment scales. Additionally, observing patients' behavior and emotional responses during treatment can provide insights into their anxiety levels.

Oral Health-Related Quality of Life: The success of orthodontic treatment is not solely determined by tooth movement but also relates to patients' oral health-related quality of life indicators. These indicators may include oral hygiene habits, dietary changes, and satisfaction with the treatment process. Questionnaires, oral examinations, and oral health-related quality of life assessment tools can be used to evaluate these aspects.

Researching these areas can help us gain a better understanding of patients' experiences and needs during orthodontic treatment. This, in turn, can aid in improving treatment methods and providing better patient care. Furthermore, research findings can be used to offer education and guidance to patients before, during, and after treatment to alleviate their pain and anxiety and promote oral health maintenance.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Orthodontic patient with clinical diagnosis malocclusion
  • Age from 18 to 60 years old

排除标准

  • Systemic and psychological disease
  • Craniofacial deformity
  • Received orthodontic treatment beforehand

结局指标

主要结局

Visual Analogue Scale(VAS) pain scale

时间窗: 2 years

The pain scale illustrate the pain level which ranging from 0\~10. 0 represent no pain,and 10 represent the most painful sensation. The participant will choose the most suitable pain sensation during the testing time point.

Generalized Anxiety Disorder 7-item (GAD-7) scale

时间窗: 2 years

The GAD-7 scale using seven questions to test the anxiety level measurement caused by any problems, and how difficult have these problems interfere you to do your work, take care of things at home, or get along with other people? Each question is measured with four point Likert's scale from 0\~3 and then sum up to have the total score. The total score ranging from 0\~4: extreme mild anxiety / 5\~9: mild anxiety/ 10\~14:moderate anxiety/15\~21: severe anxiety.

Oral health impact profile(OHIP)-14 scale; self-administered questionnaire

时间窗: 2 years

The OHIP-14 scale was used to measure the participants' oral health related quality of life and it has seven conceptualized domains (two items per domain): functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.In which, respondents are asked to rate how frequently they experienced an oral health impact (as described by each item). In turn, the response to each item is scored on a five-point Likert scale: 0, never; 1, hardly ever; 2, occasionally; 3, fairly often; and 4, very often or every day. Thus, summary OHIP-14 scores can range from 0 to 56. A high total value indicates a high negative impact on the OHRQoL.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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