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临床试验/NCT07032012
NCT07032012尚未招募不适用

The Impact of Pre-anesthetic Evaluation on the Anxiety of Orthopedic Patients: a Randomized Clinical Trial.

Hospital de Base0 个研究点目标入组 100 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Pre operative anxiety levels

研究概览

简要总结

Since the last century, it has been understood that "the pre-anesthetic evaluation is the patient's right and the anesthesiologist's duty." As early as 2006, the Conselho Federal de Medicina (CFM) published a resolution addressing the anesthetic act and guiding the conduct of pre-anesthetic evaluation (PAE) and in 2017 revised these guidelines in a new resolution. The PAE is an important step in preparing the patient for elective surgical procedures. It refers to the moment when the anesthesiologist and patient have the opportunity to get to know each other, optimize the patient's clinical conditions and even request exams or consult other specialists when necessary. The prevalence and levels of anxiety, commonly generated by the expectation of the surgical-anesthetic procedure, tend to reduce with the PAE. This leads to fewer patients presenting to the operating room with arterial hypertension or arrhythmia, which are triggered by anxiety. It can be said that the implementation of the PAE directs screening processes and consequently reduces the patient's risk to unnecessary procedures or consultations. It also highlights the reduction in perioperative morbidity and mortality rates. By analyzing the dynamics of the surgical center, where the space is highly technological and contested by various surgical specialties, it is possible to associate the PAE with the reduction in cancellation rates of procedures and the proper use of space. Measuring sentiment is difficult and to assess anxiety, one can use complex questionnaires to small and objective scales. Some studies show how anxiety can contribute to increased postoperative pain, higher medication consumption, and longer hospitalization time. A possible tool to change this scenario would be the PAE, but its relationship with anxiety still needs to be further documented, especially in Brazil. Therefore, this project seeks to study the hypothesis that the PAE reduces anxiety levels, brings quality to the anesthetic-surgical experience, and improves perioperative morbidity indicators. This study aims to evaluate the impact of pre-anesthetic evaluation on perioperative surgical outcomes in patients of the orthopedic specialty undergoing procedures at the institution. It aims to identify the anxiety level of patients undergoing orthopedic surgery. This randomized clinical trial will be conducted at the Hospital de Base do Distrito Federal, Brasília, Distrito Federal, Brazil.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective or urgent orthopedic surgery
  • aged between 18 and 65 years
  • ASA classification I to III

排除标准

  • Patient refusal to participate
  • Patient refusal to sign the IC
  • Lack of education
  • History of psychiatric illness, especially depression
  • Limited cognitive capacity (self-declared or informed by a companion)
  • Prolonged hospitalization (greater than or equal to 14 days)
  • Emergency surgery
  • Inability to understand the IC.

结局指标

主要结局

Pre operative anxiety levels

时间窗: Before the procedure.

Assessment of pre operative anxiety levels using the State-Trait Anxiety Inventory - anxiety scale in patients who will or will not receive pre-anesthesia assessment in orthopedic surgeries. The score on this scale ranges from 10 to 40, with 10 being the calmest possible individual and 40 being the most anxious possible.

次要结局

  • Assess anxiety levels using the Likert scale(Before the procedure)

研究者

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

Fabricio Tavares Mendonca

MD, TSA, MSc, PhD

Hospital de Base

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