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临床试验/NCT04259463
NCT04259463已完成不适用

The Influence of Sedation and General Anesthesia to Patients' Psycho-emotional State Undergoing Wisdom Teeth Extraction

Inesa Astramskaitė1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2019年10月21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
53
试验地点
1
主要终点
Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire

研究概览

简要总结

The aim of the study is to evaluate, wheather the sedation or general anesthesia in third molar extractions influence the patient's psycho-emotional status. It is believed that the type of anesthesia may influence not only the psycho-emotional status after the procedure, but also before the procedure.

详细描述

A prospective pilot study was conducted on adult patients who were admitted to the Faculty of Surgery at LSMU KK hospital for removal of all four wisdom teeth with sedation or general anesthesia. The patients were given one day to complete the given questionnaires. They were asked to complete three questionnaires: a) before the surgery, i.e. at the time the patient was hospitalized; b) the same day prior to surgery; c) ten days after the surgery. The operating doctor also filled out a questionnaire ten days after the surgery.

The aim of the study is to evaluate, wheather the sedation or general anesthesia in third molar extractions influence the patient's psycho-emotional status. It is believed that the type of anesthesia may influence not only the psycho-emotional status after the procedure, but also before the procedure.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age ≥ 18 years;
  • Indicated removal of all 4 wisdom teeth;
  • Non-use of NSAIDs, anticoagulants;
  • No acute inflammation in the operated area;
  • No history of common conditions that contraindicate oral surgery. For example, uncontrolled diabetes, cardiovascular disease;
  • Patients agreed to participate in the study.

排除标准

  • Pregnant, breastfeeding women;
  • Individuals, formerly treated with radiation;
  • Patients who participated in studies related to the assessment of psycho-emotional status;
  • Patients with obvious mental, intellectual or physical disabilities limiting the participation in the study.

结局指标

主要结局

Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire

时间窗: immediately after the intervention/procedure/surgery

Anesthesia effect on patients pre-operative psycho-emotional status. The following scales are used: Universal Scale in Oral Surgery for psycho-emotional rating (1-3 raiting with higher rating meaning more negative psycho-emotional status); Modified Corah's Dental Anxiety Questionnaire (1-5 scores with with higher rating meaning more negative psycho-emotional status); visual analogue scales on fear of tooth extraction and fear of general anesthesia (1-5 scores with higher rating meaning higher fear)

Anesthesia effect on patients post-operative psycho-emotional status: questionnaire

时间窗: 10 days after after the intervention/procedure/surgery

Anesthesia effect on patients post-operative psycho-emotional status. The following scales are used: Universal Scale in Oral Surgery for psycho-emotional rating (1-3 raiting with higher rating meaning more negative psycho-emotional status); Modified Corah's Dental Anxiety Questionnaire (1-5 scores with with higher rating meaning more negative psycho-emotional status); visual analogue scales on fear of tooth extraction and fear of general anesthesia (1-5 scores with higher rating meaning higher fear). Also the pain that was felt immediately after the procedure, 6 hours after the procedure, 24 hours after the procedure, 2-10 days after the procedure was evaluated. The linear scale of 10cm was used, where the less points ment lower pain. Patient had to point the vertical dash on a line to represent the pain

次要结局

未报告次要终点

研究者

发起方
Inesa Astramskaitė
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Inesa Astramskaitė

DDS Inesa Astramskaite Januseviciene

Lithuanian University of Health Sciences

研究点 (1)

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