What side effects are associated with this type of intervention?

Common treatments for stress, such as mindfulness, cognitive-behavioral therapy (CBT), and relaxation techniques, generally have minimal side effects. Mindfulness and relaxation techniques can sometimes lead to increased anxiety or discomfort in some individuals, particularly those with a history of trauma. CBT is generally well-tolerated but may cause temporary emotional discomfort as individuals confront and work through stressors. Biofeedback, which involves monitoring physiological signals to manage stress, is also considered safe with few side effects, though some users may experience mild discomfort or anxiety when first learning to use the technology.

What prior FDA approvals exist?

The FDA has approved various treatments for stress, including pharmacological options like SSRIs (e.g., paroxetine, fluoxetine) and non-pharmacological interventions such as biofeedback devices. Biofeedback, which involves monitoring physiological signals like heart rate variability (HRV) to help manage stress, has shown promise in clinical settings. The Wrist-Worn Sensor Biofeedback being studied aligns with these non-pharmacological approaches, aiming to provide real-time feedback to help healthcare workers self-manage symptoms of stress and burnout.

What other types of research exist?

Promising alternatives to wrist-worn sensor biofeedback for managing stress and burnout include: <ol> <li>Mobile Apps for Cognitive Behavioral Therapy (CBT): These apps provide structured CBT programs that can help manage stress and anxiety through guided exercises and real-time feedback.</li> <li></li> </ol> Virtual Reality (VR) Therapy: VR environments can be used to create immersive relaxation experiences or simulate stress-inducing scenarios in a controlled manner to help patients develop coping strategies. 3. Telehealth Counseling: Remote therapy sessions via video calls can provide access to mental health professionals, offering personalized support and strategies for stress management. 4. Mindfulness and Meditation Apps: These apps offer guided meditation, breathing exercises, and mindfulness practices that can help reduce stress and improve mental well-being. 5. Biofeedback Devices: Other forms of biofeedback devices, such as those that monitor heart rate variability (HRV) through chest straps or finger sensors, can provide insights into physiological responses to stress and guide relaxation techniques.

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Wearable Stress Monitor for Stress Management

N/A

Waitlist Available

Led By Marie Krousel-Wood, MD, MSPH

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Be older than 18 years old

Must not have

Previous diagnosis of atrial fibrillation

Unable or unwilling to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a wristband that tracks health data to help healthcare workers manage stress and burnout. The wristband provides real-time feedback on stress levels, aiming to improve their readiness to address burnout.

Who is the study for?

This trial is for healthcare workers at FQHC, aged 18 or older, who can understand and speak English. They must have a smartphone compatible with the Biostrap sensor and app, and be working during the six-week study. Pregnant individuals, those unable to consent, with pacemakers or diagnosed atrial fibrillation cannot join.

What is being tested?

The trial is testing if a wrist-worn sensor can help healthcare workers manage stress and burnout by providing biofeedback on their physical state. Participants will use this technology over a period of six weeks to monitor their well-being.

What are the potential side effects?

Since this intervention involves wearing a sensor and using an app rather than taking medication or undergoing medical procedures, side effects are minimal but may include discomfort from wearing the device or anxiety from monitoring symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with atrial fibrillation before.

Select...

I cannot or do not want to give permission for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean in readiness to change composite score between immediate information and delayed information periods.

Secondary study objectives

Change in burnout score from baseline to 6 weeks

Other study objectives

Change in mean on participant Heart Rate Variability (HRV) between conditions

Change in mean on participant activity level score between conditions

Change in mean on participant heart rate between conditions

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Real time access start armExperimental Treatment1 Intervention

The participants will receive real-time access to their biometric data via the Biostrap API (immediate information condition). After 1 week "washout" the arms will cross-over, and the delayed access start arm will receive real-time access to their biometrics via the Biostrap API while real time access start arm is blinded to their biometric report until the end of the control period.

Group II: Delayed access start armExperimental Treatment1 Intervention

The participants are blinded to their biometrics until the control period is over (information delayed condition). After 1 week "washout" the arms will cross-over, and the delayed access start arm will receive real-time access to their biometrics via the Biostrap API while real time access start arm is blinded to their biometric report until the end of the control period.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Biofeedback, a common treatment for stress, involves monitoring physiological signals like heart rate, muscle tension, and skin temperature to help individuals gain control over these functions. By becoming aware of their stress responses, patients can learn techniques such as deep breathing, progressive muscle relaxation, and mindfulness to manage stress effectively. This approach is significant for stress patients as it empowers them to actively participate in their stress management, potentially reducing symptoms of stress and burnout.