Biofeedback Effects on Nursing Personal at an University Hospital

NCT ID: NCT04446689

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2021-06-28

Brief Summary

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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

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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.

Conditions

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Stress (Psychology) Biofeedback, Psychology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Biofeedback

Intervention Type BEHAVIORAL

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sônia Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Sônia Souza, PhD

Role: CONTACT

+55 51 3359 8384

Facility Contacts

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Sônia Souza, PhD

Role: primary

+55 51 3359 8384

Other Identifiers

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2019-06-45

Identifier Type: -

Identifier Source: org_study_id

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