Does a Portable Biofeedback Tool Reduce Physician Stress?

Stress Clinical Trial

Official title:

Does a Portable Biofeedback Tool Reduce Physician Stress?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067183
• Other study ID #: E-22185
• Status: Completed
• Phase: N/A
• First received: February 9, 2010
• Last updated: February 17, 2010
• Start date: March 2009
• Est. completion date: July 2009

Study information

• Verified date: February 2010
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Conjoint Health Research Ethics Board
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all staff physicians at the university hospital

Exclusion Criteria:

• any physician who screens positive for major depression

Study Design

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• portable biofeedback tool and relaxation breathing technique
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

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		At day 28 for RCT, at day 56 for trial extension	No
Secondary	physiological outcomes:heart rate, blood pressure, weight and salivary cortisols		At day 28 for RTC and day 56 for trial extension	No
Secondary	physician opinions, qualitative interview data		pre and post intervention	No