<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04446689</url>
  </required_header>
  <id_info>
    <org_study_id>2019-06-45</org_study_id>
    <nct_id>NCT04446689</nct_id>
  </id_info>
  <brief_title>Biofeedback Effects on Nursing Personal at an University Hospital</brief_title>
  <official_title>Biofeedback Efects on Stress, Anxiety, and Quality of Professional Life on Nursing Staff of an University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized Clinical Trial comparing two groups: placebo group without self-monitoring of&#xD;
      heart rate variability (HRV) and biofeedback intervention that includes self-monitoring of&#xD;
      HRV&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Its main objective is to evaluate the effects of Biofeedback intervention on the stress, and&#xD;
      anxiety levels, as well as the quality of professional life, and their coping mechanisms, of&#xD;
      a nursing staff from de Hospital de Clínicas de Porto Alegre. The research will have two&#xD;
      phases, first to select the nursing staff sample, and then to apply and evaluate the&#xD;
      intervention. From 2.219 individuals will be randomly drawn a sample of 272 participants. All&#xD;
      will respond a questionnaire (Vasconcelos Symptoms and Stress List) in order to obtain a&#xD;
      general level of stress score greater than 1 (inclusion criteria to enter the RCT). The 272&#xD;
      group will be randomly split in two groups (136 subjects each) to compare the intervention vs&#xD;
      placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 28, 2020</start_date>
  <completion_date type="Anticipated">June 28, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stress</measure>
    <time_frame>4 weeks</time_frame>
    <description>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).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">272</enrollment>
  <condition>Stress (Psychology)</condition>
  <condition>Biofeedback, Psychology</condition>
  <arm_group>
    <arm_group_label>Biofeedback</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>activity without self monitoring</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.&#xD;
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.&#xD;
The control group will answer the research protocol in two moments (D1 and D8), to evaluate</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <description>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.</description>
    <arm_group_label>Biofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nursing staff&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
          -  Working activities&#xD;
&#xD;
          -  Admitted in the last 90 days&#xD;
&#xD;
          -  Presenting a level stress greater then 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and breast feeding professionals&#xD;
&#xD;
          -  Those away from work a long time, and or returning from vacations in the last 15 days.&#xD;
             ----Participants with any kind of cardiac pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sônia Souza, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clinicas de Porto Alegre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sônia Souza, PhD</last_name>
    <phone>+55 51 3359 8384</phone>
    <email>sbcs2001@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sônia Souza, PhD</last_name>
      <phone>+55 51 3359 8384</phone>
      <email>sbcs2001@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nursing staff</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04446689
org study id: 2019-06-45
nct id: NCT04446689
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Stress
time frame: 4 weeks
description: 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).
arm group label: Biofeedback
arm group type: Active Comparator
description: 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.
arm group label: activity without self monitoring
arm group type: No Intervention
description: 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
intervention type: Behavioral
intervention name: Biofeedback
description: 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.
arm group label: Biofeedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sônia Souza, PhD
role: Principal Investigator
affiliation: Hospital de Clinicas de Porto Alegre
last name: Sônia Souza, PhD
phone: +55 51 3359 8384
email: sbcs2001@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Sponsor