跳至主要内容
临床试验/NCT05731180
NCT05731180Enrolling By Invitation不适用

The Efficacy of Medical Students to Correctly Recognise Pathological From Non-pathological Lung Sounds Over a Period of Time

Lithuanian University of Health Sciences2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
140
试验地点
2
主要终点
Students' Accuracy, Specificity, Sensitivity in Identifying Pathological Lung Sounds After 3-days Training

研究概览

简要总结

Title: The efficacy of medical students to correctly recognise pathological from non-pathological lung sounds over a period of time.

Methodology: Randomised, controlled trial, blind study.

Study Duration: The estimated duration for the main protocol (e.g., from the start of screening to the last subject processed and finishing the study) is approximately 6 months.

Study Centre: Lithuanian University of Health Sciences (LSMU).

Objectives: Primary Objective: To evaluate the accuracy of second-year & third-year students in correctly identifying pathological and not pathological lung sounds. Secondary Objectives: To evaluate the loss of the ability of the student to correctly identify pathological lung sounds over a period of time.

Number of Subjects: 140 randomised students in two groups; the first group is the control group (CNT), and a second group (EXP) will be exposed to pathological and none pathological lung sounds.

Diagnosis and Main Inclusion Criteria: Inclusion Criteria · Male and female second and third-year LSMU students, 18-40 years old, in any distribution. · Consent and compliance with all aspects of the study protocol, and methods, providing data during follow-up contact · See the methods section for the full list of inclusion criteria. Exclusion Criteria · Deafness · Age over 40 · Conditions that prevent the student from using earphones · See the methods section for a full list of exclusion criteria.

Regimen: CNT group will not receive training. Whilst group will receive 3-day training for 21 patient cases (57% with pathological lung sounds).

Statistical Methodology: Results will be analysed with the SPSS (version 27). A p-value < 0.05 will be considered statistically significant. The groups (CNT vs EXP) will be compared with the independent Student's t-test to see if there is a significant difference between the mean of the two groups. Though, if the data does not adhere to the parametric test's criteria a Mann-Whitney test will be applied. Whilst for the measurement made over 6 months of students' sensitivity, specificity, and accuracy (at intervals of 4, 10, 34, 184 -days) a one-way analysis of variance (ANOVA) statistical test will be applied for normally distributed data. Whilst, if data is not normally distributed a none parametric test will be applied such as Kruskal - Wallis method. McNemar's test will be applied to compare the performances of the same EXP students between their second- and third-year peers.

详细描述

Purpose: The primary objective is to evaluate the accuracy, sensitivity and specificity of 2nd and 3rd-year medical students' accuracy in identifying pathological sounds after 3 days of training.

Secondary Objective: To evaluate the loss of the ability of the student to correctly identify pathological lung sounds over a period of time when she/he does not undergo regular training.

Background: Auscultation is one of the four pillars of patient examination [1, 2, 3], and is particularly during a pulmonary objective investigation. Today, the assessment of auscultation sounds remains largely subjective and depends on the qualifications and expertise of a specialist [4, 5]. Arts et al. [6] recommend leaving the practice of traditional auscultation to experienced specialists since sensitivity is as low as 37% when identifying between normal cases and several lung pathologies. Furthermore, auscultation skills require continuous practice and can even degrade over time [7], but can be improved through training [2]. Hence in our research were are interested to investigate the effect of training on medical students' accuracy to identify lung sounds correct. The research is created to investigate skill deterioration over a period of time. Investigator's expectations are that the research will provide us with a better understanding of how often healthcare staff should undergo training to maintain a good standard.

Goals of the study:

To evaluate the specificity, sensitivity and accuracy of 2nd and 3rd-year medical students whilst identifying lung sounds.

研究设计

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

盲法说明

The subject will be assigned a unique screening/enrolment number.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female second and third-year LSMU students;
  • 18 years and older;
  • subject that provides full written consent to participate in the study.

排除标准

  • not a second-year or third-year at LSMU;
  • deafness;
  • age over 40;
  • conditions that prevent students from using earphones;
  • subject does not provide full consent.

结局指标

主要结局

Students' Accuracy, Specificity, Sensitivity in Identifying Pathological Lung Sounds After 3-days Training

时间窗: Whilst for the measurement made mediately after training over a period of 1 day.

Key measures of medical students' specificity, sensitivity and accuracy to identify pathological lung sounds will be assessed over a period of 4 days from the initiation of training.

次要结局

  • Potential Degradation of Students' Accuracy, Specificity, and Sensitivity in Identifying Pathological Lung Sounds After 34 Days(The measurement is made 34 days after initiation of training, over a period of 1 to 2 days)
  • Potential Degradation of Students' Accuracy, Specificity, and Sensitivity in Identifying Pathological Lung Sounds After 10 Days(The measurement is made 10 days after initiation of training, over a period of 1 day)
  • Potential Degradation of Students' Accuracy, Specificity, and Sensitivity in Identifying Pathological Lung Sounds After 184 Days(The measurement is made 184 days after initiation of training, over a period of 1 to 2 days.)

研究者

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

Haroldas Razvadauskas

Doctor of Medicine

Lithuanian University of Health Sciences

研究点 (2)

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