NCT06721312

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

December 9, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

December 3, 2024

Last Update Submit

December 6, 2024

Conditions

Keywords

Heart rate variabilityHRVoccupational stressresiliencefatiguewellbeingstressburnout

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    Continuous heart rate variability over 7 day study period

    7 days

Secondary Outcomes (4)

  • Burnout

    Measured on day 1

  • Resilience

    Measured on day 1

  • Wellbeing

    Measured on day 1

  • EMA Measures

    8 times/day for 7 days

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical Doctors working within NHS Grampian

You may qualify if:

  • Working within NHS Grampian
  • Access to a smartphone

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Grampian

Aberdeen, AB25 2ZN, United Kingdom

RECRUITING

Related Publications (1)

  • Kane L, Ball D, Martin KR, Powell D. Continuous heart rate variability monitoring-understanding patterns of stress and recovery and their relationship with self-reported burnout, resilience and well-being in doctors: a protocol for a sequential explanatory mixed-methods study. BMJ Open. 2025 Jun 8;15(6):e097849. doi: 10.1136/bmjopen-2024-097849.

MeSH Terms

Conditions

Burnout, PsychologicalOccupational StressFatigue

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Leia M Kane, BSc (hons), MBChB, FRCEM

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

December 9, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations