NCT03152331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

May 1, 2017

Last Update Submit

March 6, 2019

Conditions

Keywords

Neurofeedback

Outcome Measures

Primary Outcomes (1)

  • Bispectral Index Score (BIS)

    BIS values from baseline to end of study

    Up to 28 weeks

Secondary Outcomes (2)

  • Wellbeing surveillance tool

    Up to 28 weeks

  • Likert value of each attentional state

    Up to 28 weeks

Study Arms (1)

Receptive Awareness Training

EXPERIMENTAL
Behavioral: Receptive Awareness Training

Interventions

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.

Receptive Awareness Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians (resident, attending, and assistant) at St. Elizabeth Youngstown Hospital
  • Nurses (registered, practitioner, and anesthetist) at St. Elizabeth Youngstown Hospital
  • Individuals undergoing psychological or psychiatric counseling or those requiring psychoaffective medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

Location

Related Publications (20)

  • 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.

    PMID: 24448053BACKGROUND
  • 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.

    PMID: 14734943BACKGROUND
  • 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.

    PMID: 20645421BACKGROUND
  • 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.

    PMID: 20141303BACKGROUND
  • 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.

    PMID: 26329810BACKGROUND
  • 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.

    PMID: 24019273BACKGROUND
  • 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.

    PMID: 22849035BACKGROUND
  • 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.

    PMID: 25783980BACKGROUND
  • 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.

    PMID: 27303609BACKGROUND
  • 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.

    PMID: 21568194BACKGROUND
  • 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.

    PMID: 23827814BACKGROUND
  • 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.

    PMID: 24975621BACKGROUND
  • 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.

    PMID: 18337600BACKGROUND
  • 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.

    PMID: 24937564BACKGROUND
  • 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.

    PMID: 17242086BACKGROUND
  • 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.

    PMID: 21483382BACKGROUND
  • 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.

    PMID: 15460358BACKGROUND
  • 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.

    PMID: 24109463BACKGROUND
  • 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.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • C. Michael Dunham, MD

    St. Elizabeth Youngstown Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive receptive awareness training with neurofeedback.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 15, 2017

Study Start

May 22, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations