- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515667
Mindfulness in the OR
June 26, 2025 updated by: Virginia Commonwealth University
Mindfulness in the OR: Can an Abbreviated Mindfulness Skill Improve a Surgeon's Focus, Anxiety and Performance in the OR?
The purpose of this research study is to understand the effect of a short mindfulness video on self perceived performance in the OR.
Specifically, assessing the effectiveness of brief mindfulness intervention on physician focus, anxiety and perceived performance at the time of a procedure through a survey containing a modified flow state scale and modified applied mindfulness process scale
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- 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
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- practicing physicians or medical trainees
- employed in a hospital setting
- providing surgeries in an operating room setting.
Exclusion Criteria:
• practitioners involved in counseling roles
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
|
Participants will view a control video
|
|
Experimental: Mindfulness
|
Participants will view a brief mindfulness video
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived flow
Time Frame: At the end of the procedure, up to 5 hours
|
Perceived flow will be assessed using a modified flow state scale after case.
Items are rated from Strongly disagree to Strongly agree.
Items are summed and scored.
|
At the end of the procedure, up to 5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived application of mindfulness
Time Frame: at the end of the procedure, up to 5 hours
|
Perceived mindfulness will be assess using a modified applied mindfulness process scale.
Items are rated never, rarely, sometimes, often and always.
Items are summed and scored.
|
at the end of the procedure, up to 5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frances Casey, MD, Virginia Commonwealth University
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)
October 6, 2020
Primary Completion (Actual)
February 7, 2024
Study Completion (Actual)
February 7, 2024
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 13, 2020
First Posted (Actual)
August 17, 2020
Study Record Updates
Last Update Posted (Actual)
June 29, 2025
Last Update Submitted That Met QC Criteria
June 26, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- HM20018279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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