- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721312
Continuous Heart Rate Variability Monitoring in Doctors; Understanding Patterns of Stress and Recovery and Their Relationship With Self-reported Resilience, Burnout and Wellbeing. (HEART-ED)
Burnout is an increasing concern in the medical professions. This study aims to utilise established, validated self-report measures combined with continuous heart rate variability measurements to better understand the stress and recovery patterns experienced by doctors that may contribute to burnout.
This mixed methods study design will consist of an ecological momentary assessment phase where participants will complete commonly used and validated real-time subjective measures while concurrently wearing a heart rate variability monitor to provide an objective measure of stress. Following on from this, participants of interest will be invited to participate in semi structured interviews to further explore their experiences of stress and recovery.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aberdeen, United Kingdom, AB25 2ZN
- NHS Grampian
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Working within NHS Grampian
- Access to a smartphone
Exclusion Criteria:
- Cardiac arrhythmias/endocrine disease.
- Prescription beta blockers, calcium channel blockers, ACE inhibitors, benzodiazepines, antidepressants and antianxiety medications.
- Insufficient non-working time prior to study commencement.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heart rate variability
Time Frame: 7 days
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Continuous heart rate variability over 7 day study period
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Burnout
Time Frame: Measured on day 1
|
Maslach Burnout Inventory - 22 item scale measuring occupational burnout. Each item asks participants to rank on a scale from never to every day. An overall score is then calculated from the results. |
Measured on day 1
|
|
Resilience
Time Frame: Measured on day 1
|
Resilience Scale for Adults The RSA is a 33-item self-report scale examining intrapersonal and interpersonal factors presumed to assist them to be able to adapt to adversities.
Responses are provided via 5-point Likert scale.
|
Measured on day 1
|
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Wellbeing
Time Frame: Measured on day 1
|
ICOPPE Wellbeing Scale The I-COPPE scale(21) has 6 individual domains of interpersonal, community, occupational, physical, psychological, and economic - all of which have been individually validated against overall wellbeing.
The scale asks participants to rate each of the wellbeing domains at three different time points, now, one year previously and one year in the future totalling 21 items.
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Measured on day 1
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EMA Measures
Time Frame: 8 times/day for 7 days
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Real-Time Job Demands NASA task load index (NASA TLX) is a multidimensional workload assessment tool. It contains six subscales of mental demand, physical demand, temporal demand, performance, effort, and frustration. The overall workload is derived from an average of the six subscales listed. Real-Time Job Resources This is a six-item scale derived from the job-demands resources model of burnout. The items contained within the scale are feedback, rewards, job control, participation, job security and supervisor support. Flow Included is a single item question asking participants "have you felt completely absorbed by a challenging but doable task". Given the paucity of literature understanding what "flow" might mean within this study population and how this may relate to HRV there is a free text box allowing participants to expand on their experience. Fatigue The Rating of Fatigue (ROF) scale(59)is a single-item visual analogue scale. |
8 times/day for 7 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-015-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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