Nurse and Physician Stress Reduction: Learning Receptive Awareness Via EEG Feedback
Primary Purpose
Stress, Stress, Psychological, Electroencephalography
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receptive Awareness Training
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring Neurofeedback
Eligibility Criteria
Inclusion Criteria:
- Physicians (resident, attending, and assistant) at St. Elizabeth Youngstown Hospital
- Nurses (registered, practitioner, and anesthetist) at St. Elizabeth Youngstown Hospital
Exclusion Criterion:
- Individuals undergoing psychological or psychiatric counseling or those requiring psychoaffective medications
Sites / Locations
- St. Elizabeth Youngstown Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Receptive Awareness Training
Arm Description
Outcomes
Primary Outcome Measures
Bispectral Index Score (BIS)
BIS values from baseline to end of study
Secondary Outcome Measures
Wellbeing surveillance tool
Wellbeing from baseline to end of study was assessed using the wellbeing surveillance tool, which included elements from the Depression, Anxiety and Stress Scale, Perceived Stress Scale, Positive and Negative Affect Schedule, Medical Outcomes Study Sleep Scale, and Maslach Burnout Inventory
Likert value of each attentional state
By computing a mean Likert value for each of four attentional states (all learning days), the effect of each state on reducing the BIS value was rated: 1. widening the visual field, 2. reducing effort, 3. attention to space, and 4. relaxed alertness
Full Information
NCT ID
NCT03152331
First Posted
May 1, 2017
Last Updated
March 6, 2019
Sponsor
C. Michael Dunham
Collaborators
St. Elizabeth Youngstown Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03152331
Brief Title
Nurse and Physician Stress Reduction: Learning Receptive Awareness Via EEG Feedback
Official Title
Nurse and Physician Stress Reduction: Learning Receptive Awareness Via EEG Feedback
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
C. Michael Dunham
Collaborators
St. Elizabeth Youngstown Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate a model of mindfulness and neurofeedback among physicians and nurses. Several hypotheses will be tested: 1) BIS values will decrease as the number of sessions increase, 2) wellbeing scores will increase as the number of learning sessions increase, 3) wellbeing scores will be associated with BIS values, and 4) different attentional states will have more or less influence on reducing the BIS value.
Detailed Description
For nurses and physicians, concerns exist relative to emotional exhaustion, burnout, and job dissatisfaction. In a study of medical students (median age 25 years), residents/fellows (median age 31 years), and early career physicians (median age 37 years), adverse manifestation rates were 30-40% for emotional exhaustion, 40-50% for burnout, 40-60% for depression, 7-9% for suicidal ideation, and 50-60% for fatigue. The rate of emotional exhaustion, a risk for burnout, has been found to be substantial in nurses in the U.S.
Mindfulness is an attitudinal expression of receptive awareness, wherein there is a distinction made between an experience occurring in the present moment and associated thoughts and interpretations about the experience. The thinking process itself is observed with all thoughts being treated as equal in value, without attraction or rejection. In two investigations that consisted of physicians and nurses, a high mindfulness score was associated with less stress, greater wellbeing, and a positive emotional tone among subjects. Mindfulness training has been associated with reductions in stress or burnout risk in studies that include nurses and physicians.
Neurofeedback (NFB) is a process in which an individual learns to intentionally alter their brainwave activity. NFB has been demonstrated to be useful for decreasing anxiety and enhancing attention.
As concerns with electroencephalographic (EEG) artifacts and the fact that technologies for providing quantitative EEG analysis are continuously evolving, the investigators selected the Bispectral Index (BIS) monitor (Aspect Medical Systems, Newton, MA) as a device to provide NFB signals. The Food and Drug Administration classifies the BIS monitor as an EEG monitoring device that monitors EEG signals, and it may be used for monitoring the effects of anesthetic and sedating agents. The credibility and validity of the device is supported by more than 2,500 citations in the National Library of Medicine that includes publications in the New England Journal of Medicine and Cochrane Systematic Review.
Reductions in BIS values have also been found for conditions other than pharmacologic sedation and include acupressure, stage I sleep, and relaxation using guided imagery.
Although combining mindfulness and NFB has been advocated, such a model, to the investigators' knowledge, has not been evaluated. Therefore, the purpose of the proposed study is to evaluate a model of mindfulness and NFB among physicians and nurses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Stress, Psychological, Electroencephalography
Keywords
Neurofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive receptive awareness training with neurofeedback.
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receptive Awareness Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Receptive Awareness Training
Intervention Description
Two 12-minute learning sessions will be conducted for each learning day. Separate instructions will be provided before session 1 and before session 2 to facilitate receptive awareness. The participant is seated in front of a BIS monitor and learns that the BIS number will decrease when in a state of receptive awareness. The trainee will learn to use attentional flexibility in daily activities and adopt willful attention (focal concentration) alternatively with receptive awareness (relaxed attention), as a situation dictates.
Primary Outcome Measure Information:
Title
Bispectral Index Score (BIS)
Description
BIS values from baseline to end of study
Time Frame
Up to 28 weeks
Secondary Outcome Measure Information:
Title
Wellbeing surveillance tool
Description
Wellbeing from baseline to end of study was assessed using the wellbeing surveillance tool, which included elements from the Depression, Anxiety and Stress Scale, Perceived Stress Scale, Positive and Negative Affect Schedule, Medical Outcomes Study Sleep Scale, and Maslach Burnout Inventory
Time Frame
Up to 28 weeks
Title
Likert value of each attentional state
Description
By computing a mean Likert value for each of four attentional states (all learning days), the effect of each state on reducing the BIS value was rated: 1. widening the visual field, 2. reducing effort, 3. attention to space, and 4. relaxed alertness
Time Frame
Up to 28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Physicians (resident, attending, and assistant) at St. Elizabeth Youngstown Hospital
Nurses (registered, practitioner, and anesthetist) at St. Elizabeth Youngstown Hospital
Exclusion Criterion:
Individuals undergoing psychological or psychiatric counseling or those requiring psychoaffective medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Michael Dunham, MD
Organizational Affiliation
St. Elizabeth Youngstown Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24448053
Citation
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Nurse and Physician Stress Reduction: Learning Receptive Awareness Via EEG Feedback
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