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).

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Behavioral: portable biofeedback tool and relaxation breathing technique

Detailed 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Foothills Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all staff physicians at the university hospital

Exclusion Criteria:

• any physician who screens positive for major depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: breathing and biofeedback device; This group of physicians were trained in the use of the relaxation breathing technique and the biofeedback device, and then used this portable stress reduction tool on a daily basis with twice weekly visits with the research team. After the 28 day RCT, they were invited to continue to use the device at their discretion during a trial extension from day 28-56 to see if any effect measured was maintained.	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; Other Names: emwave personal stress reliever
No Intervention: control arm; This group did not undergo training in the breathing technique and use of the PSMD during the RTC trial day 0-28, but were visited twice weekly by the research team to collect outcome data. During the trial extension Day 28-56, this group did undergo a 1 hr training session with the PSMD and invited to use it at their discretion over the 28 days. Effectiveness outcome data (day 28-56) was collected at day 56.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
physiological outcomes:heart rate, blood pressure, weight and salivary cortisols	At day 28 for RTC and day 56 for trial extension
physician opinions, qualitative interview data	pre and post intervention

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Health services

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 11, 2010

Study Record Updates

• Last Update Posted (Estimate): February 19, 2010
• Last Update Submitted That Met QC Criteria: February 17, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: stress reduction; physician wellness
• Other Study ID Numbers: E-22185