A Virtual Reality Mindfulness-based Intervention for Nurse Managers

July 28, 2025 updated by: Beth Steinberg, Ohio State University

A Virtual Reality Mindfulness-based Intervention: The Impact and Acceptability for Nurse Managers in an Academic Medical Center

A pilot intervention wait-list control study evaluating the effectiveness of a worksite, on-demand virtual reality mindfulness intervention. Outcomes of interest include perceived stress, burnout, work engagement, resilience and respiratory rates. System usability of the VR mindfulness program and integration into the clinical workday will also be assessed for both groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pilot intervention waitlist control study will evaluate the effectiveness of an 8-week on-demand worksite virtual reality mindfulness-based intervention with academic medical center nurse managers and assistant nurse managers. Individual outcome measures will include perceived stress, burnout, resilience, work engagement, weekly respiratory rates, system usability and integration of the intervention into the workday. The study will use a convenience sample of nurse managers and assistant nurse managers recruited from across The Ohio State University Wexner Medical Center. All participants will provide informed consent which will describe the intervention and wait list control groups, the intervention, and the intervention timelines per requirements of the institutional Internal Review Board. After randomization into intervention and waitlist control groups, all participants will complete outcome measures at the same time one week before the initiation of the VR intervention group, one week after the last day of the VR intervention for the intervention group, and again one week after the waitlist control group receives the VR intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older
  • Employed as a Nurse Manager or Assistant Nurse Manager at The Ohio State University Wexner Medical Center
  • Manage a hospital-based department/unit with supervisory responsibility
  • Ability to participate in study for 8 consecutive weeks using VR technology, three times a week for 10-15-minute sessions during work hours

Exclusion Criteria:

  • Less than 18 years of age
  • Pregnant
  • Not employed as a Nurse Manager or Assistant Nurse Manager at The Ohio State University Wexner Medical Center
  • Inability to participate in study for 8 consecutive weeks using VR technology, three times a week for 15-minute sessions during work hours.
  • Does not have a personal smart phone or computer to access app.
  • Inability to read and/or understand English (consent and questionnaires in English)
  • Medical or other conditions that would preclude use of Virtual Reality technology such as:
  • Epilepsy or neurological conditions where visual stimuli may trigger seizures or other issues, sensitivity to light or motion, current pregnancy, or any injuries that would prevent operating a headset, history of motion sickness or nausea, history of migraines or headaches, history of balance issues or dizziness, pregnancy, recent concussions, or other conditions where dizziness, nausea or headaches are more likely
  • Any exclusions determined from the VR Prescreening Questionnaire for Pre-existing Conditions or Prescreening Eligibility Questionnaire.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Participation in the virtual reality mindfulness intervention the first 8 weeks
Behavioral: Virtual Reality Mindfulness intervention
Mindfulness will be offered via a virtual reality headset; participants will use the virtual reality mindfulness program 3 times per week (15 minutes at a time) for 8 weeks.
Active Comparator: Wait-list control group
will participate in the virtual reality mindfulness intervention during the second 8 weeks of the study
Behavioral: Virtual Reality Mindfulness intervention
Mindfulness will be offered via a virtual reality headset; participants will use the virtual reality mindfulness program 3 times per week (15 minutes at a time) for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress
Time Frame: Baseline and on completion of the 8-week intervention
Perceived Stress Scale-10 (PSS-10). A 10-item self-report measure of perceived stress. It is a measure of the degree to which situations in one's life are appraised as stressful over the past month. The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Baseline and on completion of the 8-week intervention
Maslach Burnout Inventory (MBI-HSS)
Time Frame: baseline and on completion of the 8-week intervention
The MBI-HSS is a self-report assessment of perceptions of burnout specific to healthcare providers. The 22-items describe job-related feelings that healthcare providers may experience in the workplace and encompasses three sub scales of emotional exhaustion, depersonalization, and personal accomplishment. The Likert scale responses include 0 (never), 1 (a few times a year or less), 2 (once a month or less), 3 (a few times a month), 4 (once a week), 5 (a few times a week), and 6 (every day). Each sub scale can have a total score of low, moderate, or high with emotional exhaustion scores: low 0-18, moderate 19-26, high 27 or greater; depersonalization scores: low 0-5, moderate 6-9, high 10 or greater; and personal accomplishment scores: low greater than 40, moderate 34-39, and high 0-33.
baseline and on completion of the 8-week intervention
Resilience
Time Frame: baseline and on completion of the 8-week intervention
The Connor-davidson Resilience Scale-10 (CD-RISC-10) is a 10-item self-report assessment of a person's ability to bounce back after adversity. A 5-point Likert Scale for each statement ranges from 0 (Not True at All), 1 (Rarely True), 2 (Sometimes True), 3 (Often True), 4 (True Nearly All of the Time). A respondent's total score can range from 0 to 40 with higher scores indicating higher resilience.
baseline and on completion of the 8-week intervention
Work engagement
Time Frame: baseline and on completion of the 8-week intervention
The Utrecht Work Engagement Scale-9 (UWES-9) is a 9-item assessment of attitudes towards one's job. The UWES-9 measures three primary factors including dedication, vigor, and absorption. Each subscale score, answered on a seven-point Likert scale ranging from 0 (Never), 1 (Almost never, a few times a year or less), 2 (Rarely, once a month or less), 3 (Sometimes, a few times a month), 4 (Often, once a week), 5 (Very often, a few times a week), and 6 (Always, every day), has a range of 0 to 18. Higher scores for each sub scale indicate higher dedication, vigor, and absorption with work.
baseline and on completion of the 8-week intervention
Respiratory rate
Time Frame: The 30-second count of inhalations will be completed by the participant before and after using the virtual reality mindfulness intervention at least three times per week for the entirety of the 8-week intervention
A self-measured count of inhalations (respiratory rate) taken over a 30-second time period. The participant will place their right hand over their left chest and count inhalations for a 30-second time period before they participate in the virtual reality mindfulness intervention and after they participate in the virtual reality mindfulness intervention.
The 30-second count of inhalations will be completed by the participant before and after using the virtual reality mindfulness intervention at least three times per week for the entirety of the 8-week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: Completed after the 8-week intervention
The System Usability Scale (SUS) is a 10-item scale measuring usability of a new technology or system. In this study, the SUS will be used to measure the usability of the virtual reality mindfulness intervention. Participants respond to each statement using a 5 point Likert Scale that ranges from 1 (strongly disagree), 2 (disagree), 3 (neither disagree or agree), 4 (agree), and 5 (strongly agree). Total scores range from 0-100 with higher scores indicating higher usability. In general, scores > 80 indicate high usability with scores 50 or less indicating low usability.
Completed after the 8-week intervention
Feasibility of Intervention Measure
Time Frame: Participants will complete after completion of the 8-week intervention
The Feasibility of Intervention Measure (FIM) is a 4-item self-report assessment to evaluate integration of the mindfulness-based intervention into the daily workflow of the nurse manager. Each statement is scored with a 5-point Likert Scale that includes 1 (completely disagree), 2 (disagree), 3 (neither agree nor disagree), 4 (agree), and 5 (completely agree). Total scores range from 4-20 with higher total scores indicating higher feasibility.
Participants will complete after completion of the 8-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024B0251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that will be shared will include mean participant age (years) , mean time as a Registered Nurse (years/months), mean time in a Nurse Manager role (years/months), mean number of direct reports, overview of nursing specialities represented in the participant sample, i.e. Medical-Surgical, Intermediate Care, Critical Care, Ambulatory, Other (Peri-op, Obstetrical). In addition, differences in mean pre-intervention and post-intervention scores for intervention and wait-list control groups, significance and effect sizes. De-identified, curated data will be entered into Dryad, an online repository endorsed by The Ohio State University.

IPD Sharing Time Frame

IPD will be available 10-30-2025 and be accessible indefinitely.

IPD Sharing Access Criteria

De-identified and curated demographic, statistical data, study overview, study consent will be accessible to academic researchers and educators through a data accessibility link once the Dryad submission is finalized.

IPD Sharing Supporting Information Type

  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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