Biofeedback Effects on Nursing Personal at an University Hospital

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT04446689

Collaborator

(none)

272

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stress (Psychology) Biofeedback, Psychology	Behavioral: Biofeedback	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

272 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 28, 2020

Actual Primary Completion Date :

Jun 15, 2020

Anticipated Study Completion Date :

Jun 28, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil	90035903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT04446689

Other Study ID Numbers:

2019-06-45

First Posted:

Jun 25, 2020

Last Update Posted:

Jun 25, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital de Clinicas de Porto Alegre

nursing staff

Study Results

No Results Posted as of Jun 25, 2020