Biofeedback Effects on Nursing Personal at an University Hospital

Not Applicable

• Conditions: Stress (Psychology); Biofeedback, Psychology

• Registration Number: NCT04446689
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2020-02-28
• Status Verified: 2020-06
• Primary Completion: 2020-06-15
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25
• Study Completion: 2021-06-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stress	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).

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil