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OpenTrials
Completed

NCT Number: NCT01067183

Does a Portable Biofeedback Tool Reduce Physician Stress?

Given the nature of their work duties and work environment, physicians often experience stress within the workplace and chronic stress negatively impacts physician wellness. Physician wellness is now linked to quality of patient care. The stress response can be broken down into four components: the stressor, the reaction, the physiological response and the experience of the physiological response. Stress can also be absolute (e.g. threat to life) and relative (e.g. I have 3 more consults to see). Stress management refers to a range of processes that are intended to mitigate one or more aspects of the psychobiology of stress. Biofeedback is a useful way of providing guidance and reinforcement for successful management of the physiological response to stress. It is important to provide physicians with effective tools for stress management. The objective of this study is to compare measures of stress and well-being among physicians allocated to learn a relaxation breathing technique and to use a biofeedback tool (referred to as a portable stress management device or PSMD) for 28 days (intervention group) and those allocated to standard care for 28 days (control group).

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Center

Calgary, Alberta, T2N 4N1, Canada

About this study

After completion of the 28 day RCT with a control group and an intervention group, we conducted a trial extension for an additional 28 days. During that time, the original control group was trained in the use of the portable stress management device and used it, without support of the research team, for 28 days. Also during that time, the original intervention group were told that they could keep the PSMD and use it as they like. At the end of the 28 day trial extension, stress, and physiological parameters were measured again. For the initial control group, this allowed us to test effectiveness of the PSMD (real life 1 hr training on the device then unsupported use). For the initial intervention group, this allowed us to see if any effects of using the PSMD were maintained for an additional 28 days, without ongoing support from the research team.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all staff physicians at the university hospital

Exclusion criteria

  • any physician who screens positive for major depression

Treatment and study plan

portable biofeedback tool and relaxation breathing technique

Behavioral

The intervention group were trained in relaxation breathing technique and the use of a portable biofeedback tool that informs them of the success of the technique...thus behavioral therapy using a biofeedback device

Other names: emwave personal stress reliever

Primary outcomes

  1. Stress questionaire developed by the research team using the following resources: 1) the Sheldon Cohen Perceived Stress Scale, 2) Personal and Organizational Quality Assessment-Revised, 3) physician responses describing stress in their words.

    Time frame: At day 28 for RCT, at day 56 for trial extension

Secondary outcomes

  1. physiological outcomes:heart rate, blood pressure, weight and salivary cortisols

    Time frame: At day 28 for RTC and day 56 for trial extension

  2. physician opinions, qualitative interview data

    Time frame: pre and post intervention

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 11, 2010
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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