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Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01067183
Study type Interventional
Source University of Calgary
Contact
Status Completed
Phase N/A
Start date March 2009
Completion date July 2009

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