Does a Portable Biofeedback Tool Reduce Physician Stress?

This study has been completed.
Sponsor:
Collaborator:
AHS Cancer Control Alberta
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01067183
First received: February 9, 2010
Last updated: February 17, 2010
Last verified: February 2010
  Purpose

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).


Condition Intervention
Stress
Behavioral: portable biofeedback tool and relaxation breathing technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does a Portable Biofeedback Tool Reduce Physician Stress?

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physiological outcomes:heart rate, blood pressure, weight and salivary cortisols [ Time Frame: At day 28 for RTC and day 56 for trial extension ] [ Designated as safety issue: No ]
  • physician opinions, qualitative interview data [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all staff physicians at the university hospital

Exclusion Criteria:

  • any physician who screens positive for major depression
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067183

Locations
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: Dr Jane Lemaire, University of Calgary
ClinicalTrials.gov Identifier: NCT01067183     History of Changes
Other Study ID Numbers: E-22185
Study First Received: February 9, 2010
Last Updated: February 17, 2010
Health Authority: Canada: Conjoint Health Research Ethics Board

Keywords provided by University of Calgary:
stress reduction
physician wellness

ClinicalTrials.gov processed this record on July 26, 2014