Mindfulness With Biofeedback

NCT02769403 | Completed

• 1 other identifier: 201600018
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mindfulness Training

Keywords

Job Satisfaction; Job Performance; Primary Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

  For the 12 weeks prior to the study and during the 12 week study period

Study Arms (2)

Treatment

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.

Device: HeartMath EmWAVE Pro; Other: Questionnaires; Other: Blood Pressure and Heart Rate; Other: Sick Days; Other: Patient Satisfaction

Control

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.

Device: HeartMath EmWAVE Pro; Other: Questionnaires; Other: Blood Pressure and Heart Rate; Other: Sick Days; Other: Patient Satisfaction

Interventions

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

Control; Treatment

Questionnaires OTHER

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

Control; Treatment

Blood Pressure and Heart Rate OTHER

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

Control; Treatment

Sick Days OTHER

Sick days during the 12 week study period will be collected

Control; Treatment

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.

Control; Treatment

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

Hampton Oaks

Gainesville, Florida, 32607, United States

Location

Halie Plantation

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires; Blood Pressure; Heart Rate; Sick Leave

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Salaries and Fringe Benefits; Income; Socioeconomic Factors; Population Characteristics; Personnel Management; Organization and Administration; Health Services Administration

Study Officials

• Frank Orlando, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: January 29, 2018

Record last verified: 2017-05

Locations

US (2)