Microbreaks in the OR to Mitigate High Physical and Mental Demands (OR-STRETCH)

February 9, 2018 updated by: Susan Hallbeck, Ph.D., Mayo Clinic

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Over the age of 21
  3. As feasible, equal numbers of males, females and minorities
  4. Performing greater than 50% of the surgery

Exclusion Criteria:

  1. Participants who are visibly unwell or report being unwell at time of study
  2. Participants unable to devote the minimum time required to complete study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Micro-Break with Dynamic Activity
Micro Break with web based application of a video to lead surgeons through dynamic exercise activities
Other: Micro Break with Dynamic Exercise Activities
Surgeons may elect to activate a web application (video) and perform targeted intraoperative exercises.
No Intervention: Comparator
A baseline survey will be completed following a surgical day with no dynamic activities

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Hallbeck, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-006129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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