NCT05395221

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

May 11, 2022

Last Update Submit

January 8, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Virtual Reality Assisted Meditation+ no intervention Group

EXPERIMENTAL

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

No intervention + Virtual Reality Assisted Meditation group

EXPERIMENTAL

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

Interventions

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.

No intervention + Virtual Reality Assisted Meditation groupVirtual Reality Assisted Meditation+ no intervention Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Vishal Thanik

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 27, 2022

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP
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.
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.