Mindfulness TrainingNCT02769403
Mindfulness With Biofeedback
A study testing HeartMath EmWAVE Pro, Questionnaires and Blood Pressure and Heart Rate in people with Mindfulness Training, run by University of Florida at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Training
- What is being tested?
- HeartMath EmWAVE Pro, Questionnaires and Blood Pressure and Heart Rate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anyone not working at Hampton Oaks and Haile Plantation at UF Health
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hampton Oaks
Gainesville, Florida, 32607
Halie Plantation
Gainesville, Florida, 32608
About this study
Official title: 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.
Read the 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.
- Conditions
- Mindfulness Training
- Being tested
- HeartMath EmWAVE Pro, Questionnaires, Blood Pressure and Heart Rate, Sick Days, Patient Satisfaction
- Keywords
- Job Satisfaction, Job Performance, Primary Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMath EmWAVE ProDevice
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
QuestionnairesOther
All participants will complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance.
Blood Pressure and Heart RateOther
All participants will have blood pressure and heart rate collected at baseline, week 6, and week 12.
Sick DaysOther
Sick days during the 12 week study period will be collected
Patient SatisfactionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HeartMath EmWAVE Pro; Other: Questionnaires; Other: Blood Pressure and Heart Rate; Other: Sick Days; Other: Patient Satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline, week 6, and week 12
The number of sick days will be assessed
Measured: During 12 week period
Secondary outcomes (3)
Changes in blood pressure between the groups from baseline, week 6, and week 12
Measured: Change from baseline, week 6, and week 12
Changes in heart rate between the groups from baseline, week 6, and week 12
Measured: 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.
Measured: For the 12 weeks prior to the study and during the 12 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness TrainingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Orlando, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769403
- Sponsor's protocol ID
- 201600018
- Status last verified
- May 2017
- First submitted
- 22 Apr 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Daily Mindfulness Practice With Biofeedback to Improve Job Satisfaction and Performance in a Primary Care Outpatient Clinic
- ClinicalTrials.gov ID
- NCT02769403
- Acronym / sponsor ID
- 201600018
- Conditions
- Mindfulness Training
- Keywords
- Job Satisfaction, Job Performance, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: HeartMath EmWAVE Pro, Other: Questionnaires, Other: Blood Pressure and Heart Rate, Other: Sick Days, Other: Patient SatisfactionParticipants 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. |
| Control | Active comparator | Device: HeartMath EmWAVE Pro, Other: Questionnaires, Other: Blood Pressure and Heart Rate, Other: Sick Days, Other: Patient SatisfactionParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Anyone not working at Hampton Oaks and Haile Plantation at UF Health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartMath EmWAVE ProThe 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 | Device | Control, Treatment |
| QuestionnairesAll participants will complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance. | Other | Control, Treatment |
| Blood Pressure and Heart RateAll participants will have blood pressure and heart rate collected at baseline, week 6, and week 12. | Other | Control, Treatment |
| Sick DaysSick days during the 12 week study period will be collected | Other | Control, Treatment |
| Patient SatisfactionThis 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. | Other | Control, Treatment |
Primary outcome
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.
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.
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.
The number of sick days will be assessed
Time frame: During 12 week period
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Orlando, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartMath EmWAVE Pro, Questionnaires and Blood Pressure and Heart Rate in people with Mindfulness Training, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.