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临床试验/NCT04446689
NCT04446689Unknown不适用

Biofeedback Efects on Stress, Anxiety, and Quality of Professional Life on Nursing Staff of an University Hospital

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2020年2月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
272
试验地点
2
主要终点
Stress

研究概览

简要总结

Randomized Clinical Trial comparing two groups: placebo group without self-monitoring of heart rate variability (HRV) and biofeedback intervention that includes self-monitoring of HRV

详细描述

Its main objective is to evaluate the effects of Biofeedback intervention on the stress, and anxiety levels, as well as the quality of professional life, and their coping mechanisms, of a nursing staff from de Hospital de Clínicas de Porto Alegre. The research will have two phases, first to select the nursing staff sample, and then to apply and evaluate the intervention. From 2.219 individuals will be randomly drawn a sample of 272 participants. All will respond a questionnaire (Vasconcelos Symptoms and Stress List) in order to obtain a general level of stress score greater than 1 (inclusion criteria to enter the RCT). The 272 group will be randomly split in two groups (136 subjects each) to compare the intervention vs placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Nursing staff
  • Both sexes
  • Working activities
  • Admitted in the last 90 days
  • Presenting a level stress greater then 1

排除标准

  • Pregnant and breast feeding professionals
  • Those away from work a long time, and or returning from vacations in the last 15 days. ----Participants with any kind of cardiac pathology

结局指标

主要结局

Stress

时间窗: 4 weeks

Stress evaluation will be measured by the 23 items Work Stress Scale (WST), likert scale with each item corresponding to a stressor and the reaction the subject has to it. Scores vary from 23 to 111 points, with good reliability (COM µ = 0,91). Results were obtained by the items media sum, considering occupational stress as low (values between 1 and 2), moderate (2,01 to 2,99), or high (3 to 5).

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 (2)

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