Overview

This trial is active, not recruiting.

Condition mindfulness training
Treatments heartmath emwave pro, questionnaires, blood pressure and heart rate, sick days, patient satisfaction
Phase phase 0
Sponsor University of Florida
Start date June 2016
End date May 2017
Trial size 18 participants
Trial identifier NCT02769403, 201600018

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
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
questionnaires
All participants will complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance.
blood pressure and heart rate
All participants will have blood pressure and heart rate collected at baseline, week 6, and week 12.
sick days
Sick days during the 12 week study period will be collected
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)
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.
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
questionnaires
All participants will complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance.
blood pressure and heart rate
All participants will have blood pressure and heart rate collected at baseline, week 6, and week 12.
sick days
Sick days during the 12 week study period will be collected
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.

Primary Outcomes

Measure
Changes in Minnesota Satisfaction Questionnaire - Short Form will be used to determine job satisfaction at baseline, week 6, and week 12
time frame: 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
time frame: 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
time frame: Change from baseline, week 6, and week 12
The number of sick days will be assessed
time frame: During 12 week period

Secondary Outcomes

Measure
Changes in blood pressure between the groups from baseline, week 6, and week 12
time frame: Change from baseline, week 6, and week 12
Changes in heart rate between the groups from baseline, week 6, and week 12
time frame: Change from baseline, week 6, and week 12
UF Physicians Faculty (UFP) Practice: Patient Satisfaction Survey
time frame: For the 12 weeks prior to the study and during the 12 week study period

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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

Additional Information

Official title Using a Daily Mindfulness Practice With Biofeedback to Improve Job Satisfaction and Performance in a Primary Care Outpatient Clinic
Principal investigator Frank Orlando, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Florida.