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Recruiting NCT05731856

Impact of Heart Rate Variability Modulation on Stress Management Among Physicians

No phase Interventional Burnout, Professional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apollo Wearable.
Who it may be relevant to
Registry conditions: Burnout, Professional. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Apollo Wearable
    Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phones. Participants will use the Apollo for at least 30 minutes after waking up and at least 30 minutes before bed on the corresponding settings for those times of the day. They will be given the Apollo Device TVS (10-200 Hz) to borrow, which they will be instructed to wear daily. They will be asked to wear the device until all study data is collected.

Primary outcome measures

  • Copenhagen Burnout Inventory [Time frame: Through study completion, on average 8 weeks]
  • Perceived Stress Scale (PSS-10) [Time frame: Through study completion, on average 8 weeks]
Secondary outcome measures (2)
  • The Quick Inventory of Depressive Symptomatology [Time frame: Through study completion, on average 8 weeks]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Through study completion, on average 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT05731856 · STUDY22060130

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗