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Completed

NCT Number: NCT02769403

Mindfulness With Biofeedback

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Halie Plantation, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HeartMath EmWAVE Pro

Device

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

Other

All participants will complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance.

Blood Pressure and Heart Rate

Other

All participants will have blood pressure and heart rate collected at baseline, week 6, and week 12.

Sick Days

Other

Sick days during the 12 week study period will be collected

Patient Satisfaction

Other

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

  1. 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

    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.

  2. 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

    The Perceived Stress Scale (PSS) has a range of scores between 0 and 40. A higher score indicates more stress.

  3. 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 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.

  4. The number of sick days will be assessed

    Time frame: During 12 week period

Secondary outcomes

  1. Changes in blood pressure between the groups from baseline, week 6, and week 12

    Time frame: Change from baseline, week 6, and week 12

  2. Changes in heart rate between the groups from baseline, week 6, and week 12

    Time frame: Change from baseline, week 6, and week 12

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2016
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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