Biofeedback Effects on Nursing Personal at an University Hospital

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

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

Study Overview

• Status: Unknown
• Conditions: Stress (Psychology); Biofeedback, Psychology
• Intervention / Treatment: Behavioral: Biofeedback

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 Type: Interventional
• Enrollment (Anticipated): 272
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sônia Souza, PhD; Phone Number: +55 51 3359 8384; Email: sbcs2001@gmail.com

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Sônia Souza, PhD; Phone Number: +55 51 3359 8384; Email: sbcs2001@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biofeedback; The intervention group will develop an activity with self-monitoring called Cardiovascular Biofeedback or Cardiac Frequency Variability (CFV). 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. This photoplethysmograph verifies blood flow alterations through an optical method. Cardiac frequency oscillations may be estimated both by the quantity of blood infrared lights absorbed or reflected, and by variations in blood volume and pressure. Captured physiological signs will be recorded during ten minutes by the Software Emwave Pro Plus®, which is adapted to biofeedback training.	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.
No Intervention: activity without self monitoring; The placebo group will develop an activity without self monitoring. In order to keep blindness between the groups the activities will be processed by an electronic device - the on line app Jigsaw Puzzles. This app consists of a puzzle with different levels of difficulties, and is played in a tablet. Each participant will be performing in the study during four weeks, with two encounters each week (total: four weeks). While the participant will be performing its activity he/she will be monitored by the researchers through CFV (Cardiac Frequency Variability) - with no visualization of the computer monitor. The control group will answer the research protocol in two moments (D1 and D8), to evaluate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Sônia Souza, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): June 15, 2020
• Study Completion (Anticipated): June 28, 2021

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: nursing staff
• Other Study ID Numbers: 2019-06-45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No