Biofeedback Effects on Nursing Personal at an University Hospital

Biofeedback, Psychology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446689
• Other study ID #: 2019-06-45
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: June 28, 2021

Study information

• Verified date: June 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Sônia Souza, PhD
• Phone: +55 51 3359 8384
• Email: sbcs2001[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: June 28, 2021
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Biofeedback, Psychology
• Stress (Psychology)

Intervention

Behavioral:
• Biofeedback
This intervention will be measured by the Software Emwave Pro Plus during 4 weeks, which send out a sign captured by a non-invasive sensor such as an ear lobe fixed photoplethysmograph.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress	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).	4 weeks