Mindfulness With Biofeedback

Using a Daily Mindfulness Practice With Biofeedback to Improve Job Satisfaction and Performance in a Primary Care Outpatient Clinic

The purpose of this research study is to determine if using HeartMath's biofeedback with emWave Pro daily mindfulness practice: is a practical and effective intervention to improve job satisfaction and performance of physicians, advance practice clinicians, and nurses; improves patient satisfaction; and affects resting blood pressure and heart rate when comparing baseline to follow-up measures.

Study Overview

• Status: Completed
• Conditions: Mindfulness Training
• Intervention / Treatment: Device: HeartMath EmWAVE Pro; Other: Questionnaires; Other: Blood Pressure and Heart Rate; Other: Sick Days; Other: Patient Satisfaction

Detailed Description

This research study seeks to determine if using a daily mindfulness practice with EmWave Pro HeartMath helps to achieve coherence through various standardized, interactive mindfulness techniques, such as guided meditations focusing on positive emotions, breathing, and imagery. The investigators seek to determine if using HeartMath's biofeedback with emWave Pro daily mindfulness practice: is a practical and effective intervention to improve job satisfaction and performance of physicians, advance practice clinicians, and nurses; improves patient satisfaction; and affects resting blood pressure and heart rate when comparing baseline to follow-up measures.

All participants will attend a one-time one-hour training session to explain cardiac coherence and how to use emWave Pro. Participants will be randomized to be either in the treatment group or the control group. Participants will use emWave Pro for at least one 5-minute session daily, Monday through Friday. The treatment participants will use it daily for all 12 weeks. The control participants will use it daily only for weeks 7-12. The treatment group will have the added component of weekly visits during the first 6 weeks of the study from an investigator and the research coordinator. The purpose of the weekly visits is focused on reinforcing accountability and achievement of coherence.

The participants will also complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance. Participants' blood pressure and heart rate will be collected at those three time points. Additionally, information about participants' use of HeartMath, sick days, and patient satisfaction will be collected after week 12.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • Hampton Oaks
    • Gainesville, Florida, United States, 32608
      • Halie Plantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals (physicians, Advanced Registered Nurse Practitioner (ARNPs) & Physician Assistants [advance practice clinicians], and nurses) working at the two research sites: Hampton Oaks and Haile Plantation at UF Health

Exclusion Criteria:

• Anyone not working at Hampton Oaks and Haile Plantation at UF Health

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Participants will use HeartMath EmWave Pro for at least one 5-minute session daily, Monday through Friday. The treatment participants will use it daily for all 12 weeks, and will have the added component of weekly visits for the first 6 weeks of the study from the study team. The weekly visits is focused on reinforcing accountability and achievement of coherence. The participants will also complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance. Participants' blood pressure and heart rate will be collected at those three time points. Additionally, information about participants' use of HeartMath EmWave Pro, sick days, and patient satisfaction will be collected after week 12.	Device: HeartMath EmWAVE Pro; The following information will be recorded about HeartMath use: Self-report: adherence (whether the daily session was completed), coherence score, any comments/notes about the daily session From the application: coherence ratio, coherence score, achievement score, session time, average heart rate; Other: Questionnaires; All participants will complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance.; Other: Blood Pressure and Heart Rate; All participants will have blood pressure and heart rate collected at baseline, week 6, and week 12.; Other: Sick Days; Sick days during the 12 week study period will be collected; Other: Patient Satisfaction; This will include patients who complete the satisfaction survey for the 12 weeks prior to the study and during the 12 week study period. Each patient satisfaction survey is tied to a specific healthcare provider (physicians, Advanced Registered Nurse Practitioner (ARNP) & Physician Assistants [advance practice clinicians], and nurses) and will be linked to the consented research participant.
Active Comparator: Control; Participants will use HeartMath EmWave Pro for at least one 5-minute session daily, Monday through Friday. The control participants will use it daily only for weeks 7-12. The participants will also complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance. Participants' blood pressure and heart rate will be collected at those three time points. Additionally, information about participants' use of HeartMath EmWave Pro, sick days, and patient satisfaction will be collected after week 12.	Device: HeartMath EmWAVE Pro; The following information will be recorded about HeartMath use: Self-report: adherence (whether the daily session was completed), coherence score, any comments/notes about the daily session From the application: coherence ratio, coherence score, achievement score, session time, average heart rate; Other: Questionnaires; All participants will complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance.; Other: Blood Pressure and Heart Rate; All participants will have blood pressure and heart rate collected at baseline, week 6, and week 12.; Other: Sick Days; Sick days during the 12 week study period will be collected; Other: Patient Satisfaction; This will include patients who complete the satisfaction survey for the 12 weeks prior to the study and during the 12 week study period. Each patient satisfaction survey is tied to a specific healthcare provider (physicians, Advanced Registered Nurse Practitioner (ARNP) & Physician Assistants [advance practice clinicians], and nurses) and will be linked to the consented research participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Minnesota Satisfaction Questionnaire - Short Form will be used to determine job satisfaction at baseline, week 6, and week 12	The Minnesota Satisfaction Questionnaire - Short Form (MSQ-SF) uses a 5-point Likert-type scale with 20 items. Responses range from 1 (very satisfied) - 5 (very dissatisfied) so the lower the score the higher the job satisfaction and the higher the score the lower the job satisfaction.	Change from baseline, week 6, and week 12
Changes in Perceived Stress Scale will be used to determine job satisfaction at baseline, week 6, and week 12	The Perceived Stress Scale (PSS) has a range of scores between 0 and 40. A higher score indicates more stress.	Change from baseline, week 6, and week 12
Changes in Medical Office Survey on Patient Safety will be used to determine job performance between at baseline, week 6, and week 12	The Medical Office Survey on Patient Safety (MOSOPS) is a 51-item survey that measures 12 domains of office culture conceptually related to patient safety. The lower the overall score the less job performance and the higher the score the better the job performance.	Change from baseline, week 6, and week 12
The number of sick days will be assessed		During 12 week period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure between the groups from baseline, week 6, and week 12		Change from baseline, week 6, and week 12
Changes in heart rate between the groups from baseline, week 6, and week 12		Change from baseline, week 6, and week 12
UF Physicians Faculty (UFP) Practice: Patient Satisfaction Survey	The patient satisfaction surveys are used by clinics in the UF Physicians Faculty (UFP) Practice and are managed by UFP administration. Patients are asked questions about rating their visit, instructions and explanations given during the visit, appointment scheduling, wait time, customer service, and demographics.	For the 12 weeks prior to the study and during the 12 week study period

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Frank Orlando, MD, University of Florida

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Primary Care; Job Satisfaction; Job Performance
• Other Study ID Numbers: 201600018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No