Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03152331
Other study ID # 17-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 22, 2017
Est. completion date December 31, 2018

Study information

Verified date March 2019
Source Mercy Health Ohio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States St. Elizabeth Youngstown Hospital Youngstown Ohio

Sponsors (2)

Lead Sponsor Collaborator
C. Michael Dunham St. Elizabeth Youngstown Hospital

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View 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. — View 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. — View Citation

Brandmeyer T, Delorme A. Meditation and neurofeedback. Front Psychol. 2013 Oct 7;4:688. doi: 10.3389/fpsyg.2013.00688. eCollection 2013. — View 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. — View Citation

Dias AM, van Deusen A. A new neurofeedback protocol for depression. Span J Psychol. 2011 May;14(1):374-84. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;(6):CD003843. doi: 10.1002/14651858.CD003843.pub3. Review. — View 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. Review. Erratum in: Child Adolesc Psychiatr Clin N Am. 2015 Jan;24(1):197. — View 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. — View 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. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Bispectral Index Score (BIS) BIS values from baseline to end of study Up to 28 weeks
Secondary 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 Up to 28 weeks
Secondary 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 Up to 28 weeks
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A