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Clinical Trials/NCT04446689
NCT04446689
Unknown
Not Applicable

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

Hospital de Clinicas de Porto Alegre1 site in 1 country272 target enrollmentFebruary 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress (Psychology)
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
272
Locations
1
Primary Endpoint
Stress
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2020
End Date
June 28, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Stress

Time Frame: 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).

Study Sites (1)

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