Mindfulness in the OR

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04515667
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.8
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Performance at Work	Behavioral: Mindfulness; Behavioral: Video	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Mindfulness in the OR: Can an Abbreviated Mindfulness Skill Improve a Surgeon's Focus, Anxiety and Performance in the OR?
• Actual Study Start Date: Oct 6, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness	Behavioral: Mindfulness; Participants will view a brief mindfulness video
Placebo Comparator: Control	Behavioral: Video; Participants will view a control video

Outcome Measures

Primary Outcome Measures

1. Perceived flow [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.

Secondary Outcome Measures

1. Perceived application of mindfulness [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

• Principal Investigator: Frances Casey, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT04515667
• Other Study ID Numbers: HM20018279
• First Posted: Aug 17, 2020
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 30, 2022