- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03152331
Nurse and Physician Stress Reduction: Learning Receptive Awareness Via EEG Feedback
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Youngstown, Ohio, United States, 44501
- St. Elizabeth Youngstown Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bispectral Index Score (BIS)
Time Frame: Up to 28 weeks
|
BIS values from baseline to end of study
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Up to 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 28 weeks
|
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
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Up to 28 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
- Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.
- Kemper KJ, Khirallah M. Acute Effects of Online Mind-Body Skills Training on Resilience, Mindfulness, and Empathy. J Evid Based Complementary Altern Med. 2015 Oct;20(4):247-53. doi: 10.1177/2156587215575816. Epub 2015 Mar 17.
- Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.
- Vahey DC, Aiken LH, Sloane DM, Clarke SP, Vargas D. Nurse burnout and patient satisfaction. Med Care. 2004 Feb;42(2 Suppl):II57-66. doi: 10.1097/01.mlr.0000109126.50398.5a.
- Poghosyan L, Clarke SP, Finlayson M, Aiken LH. Nurse burnout and quality of care: cross-national investigation in six countries. Res Nurs Health. 2010 Aug;33(4):288-98. doi: 10.1002/nur.20383.
- Perlman DM, Salomons TV, Davidson RJ, Lutz A. Differential effects on pain intensity and unpleasantness of two meditation practices. Emotion. 2010 Feb;10(1):65-71. doi: 10.1037/a0018440.
- Atanes AC, Andreoni S, Hirayama MS, Montero-Marin J, Barros VV, Ronzani TM, Kozasa EH, Soler J, Cebolla A, Garcia-Campayo J, Demarzo MM. Mindfulness, perceived stress, and subjective well-being: a correlational study in primary care health professionals. BMC Complement Altern Med. 2015 Sep 2;15:303. doi: 10.1186/s12906-015-0823-0.
- Beach MC, Roter D, Korthuis PT, Epstein RM, Sharp V, Ratanawongsa N, Cohn J, Eggly S, Sankar A, Moore RD, Saha S. A multicenter study of physician mindfulness and health care quality. Ann Fam Med. 2013 Sep-Oct;11(5):421-8. doi: 10.1370/afm.1507.
- Goodman MJ, Schorling JB. A mindfulness course decreases burnout and improves well-being among healthcare providers. Int J Psychiatry Med. 2012;43(2):119-28. doi: 10.2190/PM.43.2.b.
- Marzbani H, Marateb HR, Mansourian M. Neurofeedback: A Comprehensive Review on System Design, Methodology and Clinical Applications. Basic Clin Neurosci. 2016 Apr;7(2):143-58. doi: 10.15412/J.BCN.03070208.
- Dias AM, van Deusen A. A new neurofeedback protocol for depression. Span J Psychol. 2011 May;14(1):374-84. doi: 10.5209/rev_sjop.2011.v14.n1.34.
- Wang JR, Hsieh S. Neurofeedback training improves attention and working memory performance. Clin Neurophysiol. 2013 Dec;124(12):2406-20. doi: 10.1016/j.clinph.2013.05.020. Epub 2013 Jul 1.
- Simkin DR, Thatcher RW, Lubar J. Quantitative EEG and neurofeedback in children and adolescents: anxiety disorders, depressive disorders, comorbid addiction and attention-deficit/hyperactivity disorder, and brain injury. Child Adolesc Psychiatr Clin N Am. 2014 Jul;23(3):427-64. doi: 10.1016/j.chc.2014.03.001. Erratum In: Child Adolesc Psychiatr Clin N Am. 2015 Jan;24(1):197.
- Fassoulaki A, Paraskeva A, Kostopanagiotou G, Tsakalozou E, Markantonis S. Acupressure on the extra 1 acupoint: the effect on bispectral index, serum melatonin, plasma beta-endorphin, and stress. Anesth Analg. 2007 Feb;104(2):312-7. doi: 10.1213/01.ane.0000250911.43942.4e.
- Dahaba AA, Xue JX, Xu GX, Liu QH, Metzler H. Bilateral Bispectral Index (BIS)-Vista as a measure of physiologic sleep in sleep-deprived anesthesiologists. Minerva Anestesiol. 2011 Apr;77(4):388-93. Epub 2010 Dec 9.
- Hudetz JA, Hudetz AG, Reddy DM. Effect of relaxation on working memory and the Bispectral Index of the EEG. Psychol Rep. 2004 Aug;95(1):53-70. doi: 10.2466/pr0.95.1.53-70.
- Brandmeyer T, Delorme A. Meditation and neurofeedback. Front Psychol. 2013 Oct 7;4:688. doi: 10.3389/fpsyg.2013.00688. eCollection 2013. No abstract available.
- Dunham CM, Burger AL, Hileman BM, Chance EA, Hutchinson AE, Kohli CM, DeNiro L, Tall JM, Lisko P. Brainwave Self-Regulation During Bispectral IndexTM Neurofeedback in Trauma Center Nurses and Physicians After Receiving Mindfulness Instructions. Front Psychol. 2019 Sep 26;10:2153. doi: 10.3389/fpsyg.2019.02153. eCollection 2019.
- Dunham CM, Burger AL, Hileman BM, Chance EA. Learning receptive awareness via neurofeedback in stressed healthcare providers: a prospective pilot investigation. BMC Res Notes. 2018 Sep 4;11(1):645. doi: 10.1186/s13104-018-3756-0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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