Mental HealthNCT05395221
Making Resident Well-Being a (Virtual) Reality
A study testing Guided Mediation Virtual Reality App in people with Mental Health, run by NYU Langone Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Guided Mediation Virtual Reality App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current resident of NYU Langone Plastic Surgery (Academic Year 2022-2023)
- Consent to participation in the study
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- Guided Mediation Virtual Reality App
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Mediation Virtual Reality AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Guided Mediation Virtual Reality App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 month visit, 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jan 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: Study was not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vishal Thanik, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395221
- Sponsor's protocol ID
- 21-01719
- Status last verified
- Jan 2024
- First submitted
- 11 May 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Resident Well-Being a (Virtual) Reality
- ClinicalTrials.gov ID
- NCT05395221
- Acronym / sponsor ID
- 21-01719
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Assisted Meditation+ no intervention Group | Experimental | Other: Guided Mediation Virtual Reality AppThe 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. |
| No intervention + Virtual Reality Assisted Meditation group | Experimental | Other: Guided Mediation Virtual Reality AppThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current resident of NYU Langone Plastic Surgery (Academic Year 2022-2023)
- Consent to participation in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Mediation Virtual Reality AppGuided 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. | Other | No intervention + Virtual Reality Assisted Meditation group, Virtual Reality Assisted Meditation+ no intervention Group |
Primary outcome
Change in Emotional Exhaustion as measured by Maslach Burnout Inventory (MBI)
Time frame: Baseline, 3 month visit, 6 month visit
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.
Change in Depersonalization as measured by Maslach Burnout Inventory (MBI)
Time frame: Baseline, 3 month visit, 6 month visit
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.
Change in personal accomplishment as measured by Maslach Burnout Inventory (MBI)
Time frame: Baseline, 3 month visit, 6 month visit
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishal Thanik principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing Guided Mediation Virtual Reality App in people with Mental Health, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotional Exhaustion as measured by Maslach Burnout Inventory (MBI) (time frame: Baseline, 3 month visit, 6 month visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.