NCT01067183

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
Last Updated

February 19, 2010

Status Verified

February 1, 2010

Enrollment Period

4 months

First QC Date

February 9, 2010

Last Update Submit

February 17, 2010

Conditions

Keywords

stress reductionphysician wellness

Outcome Measures

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.

    At day 28 for RCT, at day 56 for trial extension

Secondary Outcomes (2)

  • 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

Study Arms (2)

breathing and biofeedback device

EXPERIMENTAL

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

control arm

NO INTERVENTION

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.

Interventions

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

Also known as: emwave personal stress reliever
breathing and biofeedback device

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all staff physicians at the university hospital

You may not qualify if:

  • any physician who screens positive for major depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N 4N1, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 11, 2010

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 19, 2010

Record last verified: 2010-02

Locations