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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02565394
Other study ID # 14-006129
Secondary ID
Status Completed
Phase N/A
First received August 13, 2015
Last updated February 9, 2018
Start date January 2, 2015
Est. completion date November 6, 2017

Study information

Verified date February 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Will targeted intraoperative exercises performed by surgeons during surgery, mitigate high physical and mental demands while enhancing performance during surgical procedures?


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date November 6, 2017
Est. primary completion date November 6, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Micro Break with Dynamic Exercise Activities
Surgeons may elect to activate a web application (video) and perform targeted intraoperative exercises.

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in surgeon's perceived physical discomfort and fatigue following surgeries where the dynamic exercises were performed as measured by questionnaire baseline to 12 weeks
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