Mindfulness With Biofeedback

Mindfulness Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769403
• Other study ID #: 201600018
• Status: Completed
• Phase: N/A
• First received: April 22, 2016
• Last updated: January 25, 2018
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness Training

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Halie Plantation	Gainesville	Florida
United States	Hampton Oaks	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	The number of sick days will be assessed		During 12 week period
Secondary	Changes in blood pressure between the groups from baseline, week 6, and week 12		Change from baseline, week 6, and week 12
Secondary	Changes in heart rate between the groups from baseline, week 6, and week 12		Change from baseline, week 6, and week 12
Secondary	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