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
1 other identifier
interventional
272
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2020
CompletedFirst Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2021
CompletedJune 25, 2020
June 1, 2020
4 months
June 19, 2020
June 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Biofeedback
ACTIVE COMPARATORThe 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.
activity without self monitoring
NO INTERVENTIONThe 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Nursing staff
- Both sexes
- Working activities
- Admitted in the last 90 days
- Presenting a level stress greater then 1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sônia Souza, PhD
Hospital de Clinicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 25, 2020
Study Start
February 28, 2020
Primary Completion
June 15, 2020
Study Completion
June 28, 2021
Last Updated
June 25, 2020
Record last verified: 2020-06