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Clinical Trials/NCT05731856
NCT05731856
Recruiting
Not Applicable

Impact of Heart Rate Variability Modulation on Stress and Recovery Among Physicians

Michelle Thompson1 site in 1 country50 target enrollmentJanuary 15, 2024

Overview

Phase
Not Applicable
Intervention
Apollo Wearable
Conditions
Burnout, Professional
Sponsor
Michelle Thompson
Enrollment
50
Locations
1
Primary Endpoint
Copenhagen Burnout Inventory
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects burnout in physicians.

Detailed Description

This study will be conducted by using a Tuned Vibroacoustic Stimulation (TVS) device(the commercially available TVS device known as the Apollo wearable), that has been shown in clinical studies at University of Pittsburgh to improve heart rate variability and recovery under stress. The Apollo wearable generates low volume sound waves that feel like a soothing touch to the skin. This study will assess whether slight modulation of heart rate variability (HRV) will result in a reduction in stress, improved recovery, and recovery in and around the hospital. Physicians will wear the Apollo device for heart rate variability modulation and complete questionnaires before and after use of the Apollo device for comparison of outcomes.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
November 1, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michelle Thompson

Faculty in Department of Family Medicine

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • UPMC attending physicians and residents. The participants must have either IOS or Android phones.

Exclusion Criteria

  • Unwillingness or inability to participate in the study
  • Currently own an Apollo device

Arms & Interventions

Apollo Intervention Arm

Eligible UPMC Physicians and Residents who consent to be part of this study will use an Apollo Device TVS (10-200 Hz) attached to the subject's wrist or ankle via a commercially available wearable vibration technology that can deliver TVS (Transcutaneous Vibratory Stimulation). The intensity will be targeted for the sensory threshold (the level at which the vibration is just noticeable), as this is where the TVS seems most effective from prior studies. Similar vibratory stimuli have been demonstrated to be safe in the literature. The intensity of the vibration will be adjusted to the subjects' comfort and can be controlled by the subject at any time.

Intervention: Apollo Wearable

Outcomes

Primary Outcomes

Copenhagen Burnout Inventory

Time Frame: Through study completion, on average 8 weeks

The Copenhagen Burnout Inventory (CBI) is a 19-item self reported measure of burnout. It contains three sub-scales measuring personal burnout, work-related burnout, and client-related burnout

Perceived Stress Scale (PSS-10)

Time Frame: Through study completion, on average 8 weeks

The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress using a 10-item survey. It is a measure of the degree to which situations in one's life are appraised as stressful.

Secondary Outcomes

  • Pittsburgh Sleep Quality Index (PSQI)(Through study completion, on average 8 weeks)
  • The Quick Inventory of Depressive Symptomatology(Through study completion, on average 8 weeks)

Study Sites (1)

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