Impact of Heart Rate Variability Modulation on Stress Management Among Physicians

Not Applicable

Completed

• Conditions: Burnout, Professional
• Interventions: Device: Apollo Wearable

• Registration Number: NCT05731856
• Lead Sponsor: Michelle Thompson

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.

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-16
• Study Start: 2024-01-15
• Primary Completion: 2024-10-09
• Study Completion: 2024-10-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apollo Intervention Arm	Apollo Wearable	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.

Primary Outcome Measures

Name	Time	Method
Copenhagen Burnout Inventory	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)	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 Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	Through study completion, on average 8 weeks	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. With a range of scores 1-21.
The Quick Inventory of Depressive Symptomatology	Through study completion, on average 8 weeks	The QIDS is a brief, 16-item self-rated assessment tool used to evaluate the symptoms of depression present in a patient during the past week.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States