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Nurse and Physician Stress Reduction: Learning Receptive Awareness Via EEG Feedback

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03152331
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
St. Elizabeth Youngstown Hospital
Information provided by (Responsible Party):
C. Michael Dunham, Mercy Health Ohio

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.

Condition or disease Intervention/treatment Phase
Stress Stress, Psychological Electroencephalography Behavioral: Receptive Awareness Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive receptive awareness training with neurofeedback.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nurse and Physician Stress Reduction: Learning Receptive Awareness Via EEG Feedback
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Receptive Awareness Training Behavioral: Receptive Awareness Training
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 Measures :
  1. Bispectral Index Score (BIS) [ Time Frame: Up to 28 weeks ]
    BIS values from baseline to end of study


Secondary Outcome Measures :
  1. Wellbeing surveillance tool [ Time Frame: Up to 28 weeks ]
    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

  2. Likert value of each attentional state [ Time Frame: Up to 28 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152331


Locations
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United States, Ohio
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States, 44501
Sponsors and Collaborators
C. Michael Dunham
St. Elizabeth Youngstown Hospital
Investigators
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Principal Investigator: C. Michael Dunham, MD St. Elizabeth Youngstown Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: C. Michael Dunham, Research Associate, Mercy Health Ohio
ClinicalTrials.gov Identifier: NCT03152331    
Other Study ID Numbers: 17-006
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by C. Michael Dunham, Mercy Health Ohio:
Neurofeedback
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms