NCT02565394

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2017

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

August 13, 2015

Last Update Submit

February 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Micro-Break with Dynamic Activity

EXPERIMENTAL

Micro Break with web based application of a video to lead surgeons through dynamic exercise activities

Other: Micro Break with Dynamic Exercise Activities

Comparator

NO INTERVENTION

A baseline survey will be completed following a surgical day with no dynamic activities

Interventions

Surgeons may elect to activate a web application (video) and perform targeted intraoperative exercises.

Micro-Break with Dynamic Activity

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Neck PainBack PainShoulder PainFatigue

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Susan Hallbeck, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Consultant II

Study Record Dates

First Submitted

August 13, 2015

First Posted

October 1, 2015

Study Start

January 2, 2015

Primary Completion

November 6, 2017

Study Completion

November 6, 2017

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations