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临床试验/CTRI/2020/12/029743
CTRI/2020/12/029743尚未招募不适用

Impact of COVID 19 on mental health of frontline healthcare workers in India

Max Smart Super Speciality Hospital1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2020年12月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
246
试验地点
1
主要终点
9-item Patient Health Questionnaire Score

研究概览

简要总结

INTRODUCTION & BACKGROUND

 The world is in the midst of the COVID19 pandemic (1, 2). Frontline healthcare workers directly involved in the diagnosis, treatment and care of patients with COVID 19 are under the risk of developing various mental health symptoms. Rising number of cases in India, overwhelming workload, use of personal protective equipment for long hours, staying away from family, feeling of being inadequately supported and other factors may contribute to mental health problems in them.

Therefore, the purpose of this study is to estimate the prevalence of stress, anxiety, depression and insomnia in frontline healthcare workers.

 OBJECTIVES

Primary objectives: To assess the impact of COVID 19 on mental health of frontline health care workers in India

Rationale for the study: COVID 19 is a highly contagious coronavirus disease which had gripped the whole world bringing unprecedented challenges to the healthcare system. With rising cases in India, it is presenting overwhelming workloads to healthcare workers and simultaneously affecting the mental well-being. There is limited data available in India on its impact on the mental health of healthcare workers working in this pandemic.

 ELIGIBILITY CRITERIA

Inclusion Criteria: Participants must satisfy all the following criteria to be included in the study:

  1. Male, female >= 18 years of age

  2. Healthcare workers (Doctors and Nurses) in hospitals taking care of COVID 19 patients

  3. Able and willing to provide informed consent.

Exclusion criteria:

Participants who meet any of the following criteria:

  1. Previously diagnosed case of any mental health disorders

OUTCOMES

Primary outcomes:

9-item Patient Health Questionnaire Score

7-item Generalized Anxiety Disorder Score

7-item Insomnia Severity Index

Perceived Stress Scale Score

STUDY DESIGN

Multicentric Cross sectional online survey-based study

2 Group Analysis

Test group- frontline healthcare workers

Control group- second line healthcare workers

Frontline healthcare workers defined as physicians and nurses in direct contact and directly involved in taking care of COVID 19 patients

Second line healthcare workers defined as physicians and nurses not in direct contact with COVID 19 patients

 SAMPLE SIZE

With a margin of error of 0.5 in our estimate on either side, the MINIMUM sample size comes to 246. The formula used for this purpose is as follows:

  where z = 1.96, L is the margin of error and sigma is the SD.

 In case dropouts are expected, you may like to begin with a larger sample to get a final sample of at least 246

Statistical Analysis

 Statistical analysis will be done using SPSS 20 for calculations. Quantitative data (i.e. the scores of four measurement tools) will be presented as mean and SD, median and IQ range in normally distributed data and not normally distributed data respectively.

 Qualitative data will be expressed as percentages and comparison between two groups will be done using chi square test and fisher’s exact test. Comparison between two groups will be done using student t test and Mann whitney test respectively.

 A level of 5% will be used for statistical significance.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Healthcare workers (Doctors and Nurses) in hospitals taking care of COVID 19 patients
  • Able and willing to provide informed consent.

排除标准

  • Participants who meet any of the following criteria: Previously diagnosed case of any mental health disorders.

结局指标

主要结局

9-item Patient Health Questionnaire Score

时间窗: At Baseline

7-item Generalized Anxiety Disorder Score

时间窗: At Baseline

Perceived Stress Scale Score

时间窗: At Baseline

7-item Insomnia Severity Index

时间窗: At Baseline

次要结局

  • No Secondary outcome(Not Applicable)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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