search
Back to results

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
C. Michael Dunham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Neurofeedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 1, 2017
Last Updated
March 6, 2019
Sponsor
C. Michael Dunham
Collaborators
St. Elizabeth Youngstown Hospital
search

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
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.
Results Reference
background
PubMed Identifier
14734943
Citation
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.
Results Reference
background
PubMed Identifier
20645421
Citation
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.
Results Reference
background
PubMed Identifier
20141303
Citation
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.
Results Reference
background
PubMed Identifier
26329810
Citation
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.
Results Reference
background
PubMed Identifier
24019273
Citation
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.
Results Reference
background
PubMed Identifier
22849035
Citation
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.
Results Reference
background
PubMed Identifier
25783980
Citation
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.
Results Reference
background
PubMed Identifier
27303609
Citation
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.
Results Reference
background
PubMed Identifier
21568194
Citation
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.
Results Reference
background
PubMed Identifier
23827814
Citation
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.
Results Reference
background
PubMed Identifier
24975621
Citation
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.
Results Reference
background
PubMed Identifier
18337600
Citation
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.
Results Reference
background
PubMed Identifier
24937564
Citation
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.
Results Reference
background
PubMed Identifier
17242086
Citation
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.
Results Reference
background
PubMed Identifier
21483382
Citation
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.
Results Reference
background
PubMed Identifier
15460358
Citation
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.
Results Reference
background
PubMed Identifier
24109463
Citation
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.
Results Reference
background
PubMed Identifier
31616348
Citation
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.
Results Reference
derived
PubMed Identifier
30180909
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs