Clinical trial NCT03152331: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Stress, Psychological
Electroencephalography
Keywords: Neurofeedback
Lead sponsor: Mercy Health Ohio
Sponsor class: OTHER
Collaborators: name: St. Elizabeth Youngstown Hospital
First posted: 2017-05-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive receptive awareness training with neurofeedback.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bispectral Index Score (BIS)
timeFrame: Up to 28 weeks
Secondary outcomes:
measure: Wellbeing surveillance tool
timeFrame: Up to 28 weeks
measure: Likert value of each attentional state
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: St. Elizabeth Youngstown Hospital
state: Ohio
Study officials:
affiliation: St. Elizabeth Youngstown Hospital
name: C. Michael Dunham, MD
role: PRINCIPAL_INVESTIGATOR
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