Attention Concentration DifficultyOR-STRETCHNCT02565394
Microbreaks in the OR to Mitigate High Physical and Mental Demands
A study testing Micro Break with Dynamic Exercise Activities in people with Attention Concentration Difficulty and Neck Pain, run by Mayo Clinic at 3 sites in United States.
Trial summary
Will targeted intraoperative exercises performed by surgeons during surgery, mitigate high physical and mental demands while enhancing performance during surgical procedures? Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Concentration Difficulty, Neck Pain, Back Pain
- What is being tested?
- Micro Break with Dynamic Exercise Activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jan 2015to 6 Nov 2017
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Attending surgeons (Cardiothoracic, Colon and Rectal, General, Gynecology and Obstetrics, Ophthalmic, Orthopedic, Otolaryngology-Head and Neck, Neurology, Urology, Plastic and Maxillofacial, Rural, Urology, Thoracic and Vascular ) or surgeons in training that are board certified or board eligible, performing open or minimally invasive surgery within the scope of their practice in the house of surgery at Mayo Clinic Rochester
- Over the age of 21
- As feasible, equal numbers of males, females and minorities
- Performing greater than 50% of the surgery
Who cannot join
- Participants who are visibly unwell or report being unwell at time of study
- Participants unable to devote the minimum time required to complete study procedures
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: OR-STRETCH: Microbreaks in the Operating Room With the Incorporation of Stretches to Mitigate High Physical and Mental Demands While Enhancing Performance During Surgical Procedures
Will targeted intraoperative exercises performed by surgeons during surgery, mitigate high physical and mental demands while enhancing performance during surgical procedures?
Read the detailed description
This study will compare the efficacy of incorporating dynamic exercises into the surgical procedure, to determine if the exercise intervention will decrease surgeon's perceived physical discomfort and fatigue and enhance self-reported performance during surgical procedures. All attending surgeons (Cardiothoracic, Colon and Rectal, General, Gynecology and Obstetrics, Ophthalmic, Orthopedic, Otolaryngology-Head and Neck, Neurology, Urology, Plastic and Maxillofacial, Rural, Urology, Thoracic and Vascular ) or surgeons in training that are board certified or board eligible, performing open or minimally invasive surgery within the scope of their practice in the house of surgery at Mayo Clinic Rochester, Arizona and Florida will be eligible to participate. Surgeons who have provided informed consent to participate will be asked to complete a preliminary baseline survey that will provide information regarding baseline participant characteristics and demographics.
The intervention is a web based application which will include a short video with verbal cues, available on computers in the Operating Rooms (ORs). This video will lead surgeons through the stretch exercises and include a timer to remind them when it is time to stretch. They will be able to set the time interval between stretches (between 20-55 minutes) and may activate a snooze on the timer to postpone the stretch to a more opportune time during the procedure. The stretches can be performed without breaking scrub, in the sterile field and can be completed in approximately 1 minute.
Surgeons will be asked to participate in this study for approximately 12 weeks , completing a baseline survey and three end of day surveys. They may use the intervention as much or as little as they choose during their participation, and will be free to use the application following study participation. The web application does track participant use, providing date and time stamps to enable the research team to track surgeon web app utilization. The application will also record how often the "snooze" was used to delay a stretch, or end stretches. After surgeons have accessed the web application, they will receive an email with a quick survey about their experiences with stretches, to assess the impact of the web app.
- Conditions
- Attention Concentration Difficulty, Neck Pain, Back Pain, Shoulder Pain, Fatigue
- Being tested
- Micro Break with Dynamic Exercise Activities
- Medical subject headings
- Neck Pain, Back Pain, Shoulder Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro Break with Dynamic Exercise ActivitiesOther
Surgeons may elect to activate a web application (video) and perform targeted intraoperative exercises.
| Study group | Role | What they receive |
|---|---|---|
| Micro-Break with Dynamic Activity | Experimental | Micro Break with web based application of a video to lead surgeons through dynamic exercise activities Receives: Other: Micro Break with Dynamic Exercise Activities |
| Comparator | No intervention | A baseline survey will be completed following a surgical day with no dynamic activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in surgeon's perceived physical discomfort and fatigue following surgeries where the dynamic exercises were performed as measured by questionnaire
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start2 Jan 2015
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Concentration DifficultyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Hallbeck, Ph.D., Mayo Clinic
- Investigators
- Susan Hallbeck, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565394
- Sponsor's protocol ID
- 14-006129
- Acronym
- OR-STRETCH
- Status last verified
- Feb 2018
- First submitted
- 13 Aug 2015
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OR-STRETCH: Microbreaks in the Operating Room With the Incorporation of Stretches to Mitigate High Physical and Mental Demands While Enhancing Performance During Surgical Procedures
- ClinicalTrials.gov ID
- NCT02565394
- Acronym / sponsor ID
- OR-STRETCH / 14-006129
- Conditions
- Attention Concentration Difficulty, Neck Pain, Back Pain, Shoulder Pain, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 1 Oct 2015 (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.
Will targeted intraoperative exercises performed by surgeons during surgery, mitigate high physical and mental demands while enhancing performance during surgical procedures?
Detailed description
This study will compare the efficacy of incorporating dynamic exercises into the surgical procedure, to determine if the exercise intervention will decrease surgeon's perceived physical discomfort and fatigue and enhance self-reported performance during surgical procedures. All attending surgeons (Cardiothoracic, Colon and Rectal, General, Gynecology and Obstetrics, Ophthalmic, Orthopedic, Otolaryngology-Head and Neck, Neurology, Urology, Plastic and Maxillofacial, Rural, Urology, Thoracic and Vascular ) or surgeons in training that are board certified or board eligible, performing open or minimally invasive surgery within the scope of their practice in the house of surgery at Mayo Clinic Rochester, Arizona and Florida will be eligible to participate. Surgeons who have provided informed consent to participate will be asked to complete a preliminary baseline survey that will provide information regarding baseline participant characteristics and demographics.
The intervention is a web based application which will include a short video with verbal cues, available on computers in the Operating Rooms (ORs). This video will lead surgeons through the stretch exercises and include a timer to remind them when it is time to stretch. They will be able to set the time interval between stretches (between 20-55 minutes) and may activate a snooze on the timer to postpone the stretch to a more opportune time during the procedure. The stretches can be performed without breaking scrub, in the sterile field and can be completed in approximately 1 minute.
Surgeons will be asked to participate in this study for approximately 12 weeks , completing a baseline survey and three end of day surveys. They may use the intervention as much or as little as they choose during their participation, and will be free to use the application following study participation. The web application does track participant use, providing date and time stamps to enable the research team to track surgeon web app utilization. The application will also record how often the "snooze" was used to delay a stretch, or end stretches. After surgeons have accessed the web application, they will receive an email with a quick survey about their experiences with stretches, to assess the impact of the web app.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-Break with Dynamic Activity | Experimental | Other: Micro Break with Dynamic Exercise ActivitiesMicro Break with web based application of a video to lead surgeons through dynamic exercise activities |
| Comparator | No intervention | –A baseline survey will be completed following a surgical day with no dynamic activities |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Attending surgeons (Cardiothoracic, Colon and Rectal, General, Gynecology and Obstetrics, Ophthalmic, Orthopedic, Otolaryngology-Head and Neck, Neurology, Urology, Plastic and Maxillofacial, Rural, Urology, Thoracic and Vascular ) or surgeons in training that are board certified or board eligible, performing open or minimally invasive surgery within the scope of their practice in the house of surgery at Mayo Clinic Rochester
- Over the age of 21
- As feasible, equal numbers of males, females and minorities
- Performing greater than 50% of the surgery
Key exclusion criteria (2 listed)
- Participants who are visibly unwell or report being unwell at time of study
- Participants unable to devote the minimum time required to complete study procedures
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 |
|---|---|---|
| Micro Break with Dynamic Exercise ActivitiesSurgeons may elect to activate a web application (video) and perform targeted intraoperative exercises. | Other | Micro-Break with Dynamic Activity |
Primary outcome
Decrease in surgeon's perceived physical discomfort and fatigue following surgeries where the dynamic exercises were performed as measured by questionnaire
Time frame: baseline to 12 weeks
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 13 Feb 2018.
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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.
Susan Hallbeck, PhD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro Break with Dynamic Exercise Activities in people with Attention Concentration Difficulty and Neck Pain, run by Mayo Clinic at 3 sites in United States.
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 4 inclusion and 2 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Decrease in surgeon's perceived physical discomfort and fatigue following surgeries where the dynamic exercises were performed as measured by questionnaire (time frame: baseline to 12 weeks). 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 13 Feb 2018.