Making Resident Well-Being a (Virtual) Reality

This study is a prospective cross-over trial examining the effect of virtual reality assisted meditation on resident reported well-being using validated scoring systems. The primary objective of this study is to evaluate the effectiveness of virtual reality guided meditation as a mechanism to improve plastic surgery resident well-being. The secondary objective is to assess resident likeliness to continue mindful meditation following completion of the study.

Study Overview

• Status: Withdrawn
• Conditions: Mental Health
• Intervention / Treatment: Other: Guided Mediation Virtual Reality App

Detailed Description

All plastic surgery residents participating will spend three months with access to virtual reality assisted meditation and three months without access to this technology. Assessment scores will be taken before and after the first three month period, and then again following the second three month period.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Current resident of NYU Langone Plastic Surgery (Academic Year 2022-2023)
• Consent to participation in the study

Exclusion Criteria:

• Any plastic surgery resident involved in conducting the study
• Any non-plastic surgery resident during the academic year 2022-2023
• Any plastic surgery resident choosing not to participate in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Assisted Meditation+ no intervention Group; The first cohort will undergo weekly virtual reality guided meditations across a three-month rotation using the Guided Mediation Virtual Reality App available on the Oculus Quest 2 Virtual Reality system (Oculus, Menlo Park, CA). After completion of the three-month time span, residents will receive no intervention during the second three-month study period. . A post-study survey will be completed to assess for various parameters including residents desire for continuation of virtual reality guided meditation following completion of the survey, subjective value of virtual reality as a tool for burnout, and likeliness to recommend virtual reality guided meditation to a colleague.	Other: Guided Mediation Virtual Reality App; Guided Meditation Virtual Reality App uses over 40 lush environments with 30 hours of guided meditations on Anxiety, Depression, Maternity, Resilience, Sleep, or Zen and 200 relaxing audio tracks using Virtual reality.
Experimental: No intervention + Virtual Reality Assisted Meditation group; The second cohort will receive no intervention during the three-month block. After completion of the three-month time span, residents will take a follow-up MBI and then will cross over to the opposite group. After completion of the second three-month study period, an additional MBI will be completed by the residents.. A post-study survey will be completed to assess for various parameters including residents desire for continuation of virtual reality guided meditation following completion of the survey, subjective value of virtual reality as a tool for burnout, and likeliness to recommend virtual reality guided meditation to a colleague.	Other: Guided Mediation Virtual Reality App; Guided Meditation Virtual Reality App uses over 40 lush environments with 30 hours of guided meditations on Anxiety, Depression, Maternity, Resilience, Sleep, or Zen and 200 relaxing audio tracks using Virtual reality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotional Exhaustion as measured by Maslach Burnout Inventory (MBI)	Emotional exhaustion as measured by Maslach Burnout Inventory (MBI) before and after virtual reality guided meditations. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Higher scores in emotional exhaustion contribute to higher levels of burnout.	Baseline, 3 month visit, 6 month visit
Change in Depersonalization as measured by Maslach Burnout Inventory (MBI)	Depersonalization as measured by Maslach Burnout Inventory (MBI) before and after virtual reality guided meditations. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Higher scores in depersonalization contribute to higher levels of burnout.	Baseline, 3 month visit, 6 month visit
Change in personal accomplishment as measured by Maslach Burnout Inventory (MBI)	Personal accomplishment as measured by Maslach Burnout Inventory (MBI) before and after virtual reality guided meditations. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Lower scores in personal accomplishment are suggestive of a more severe degree of burnout.	Baseline, 3 month visit, 6 month visit

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Vishal Thanik, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21-01719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Thomas.Calahan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No