StressNCT01067183
Does a Portable Biofeedback Tool Reduce Physician Stress?
A study testing portable biofeedback tool and relaxation breathing technique in people with Stress, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- portable biofeedback tool and relaxation breathing technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all staff physicians at the university hospital
Who cannot join
- any physician who screens positive for major depression
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Stress
- Being tested
- portable biofeedback tool and relaxation breathing technique
- Keywords
- stress reduction, physician wellness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable biofeedback tool and relaxation breathing techniqueBehavioural
Also called emwave personal stress reliever
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 28 for RCT, at day 56 for trial extension
Secondary outcomes (2)
physiological outcomes:heart rate, blood pressure, weight and salivary cortisols
Measured: At day 28 for RTC and day 56 for trial extension
physician opinions, qualitative interview data
Measured: pre and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067183
- Sponsor's protocol ID
- E-22185
- Status last verified
- Feb 2010
- First submitted
- 9 Feb 2010
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Portable Biofeedback Tool Reduce Physician Stress?
- ClinicalTrials.gov ID
- NCT01067183
- Acronym / sponsor ID
- E-22185
- Conditions
- Stress
- Keywords
- stress reduction, physician wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breathing and biofeedback device | Experimental | Behavioral: portable biofeedback tool and relaxation breathing techniqueThis 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all staff physicians at the university hospital
Key exclusion criteria (1 listed)
- any physician who screens positive for major depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| portable biofeedback tool and relaxation breathing techniqueAlso: emwave personal stress relieverThe 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 | Behavioural | breathing and biofeedback device |
Primary outcome
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
2 secondary outcomes
physiological outcomes:heart rate, blood pressure, weight and salivary cortisols
Time frame: At day 28 for RTC and day 56 for trial extension
physician opinions, qualitative interview data
Time frame: pre and post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing portable biofeedback tool and relaxation breathing technique in people with Stress, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2010.