- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06901193
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
40
Phase
- 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
-
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Wexner Medical Center
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participation in the virtual reality mindfulness intervention the first 8 weeks
|
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
|
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
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.
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baseline and on completion of the 8-week intervention
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|
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.
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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
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.
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Completed after the 8-week intervention
|
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Feasibility of Intervention Measure
Time Frame: Participants will complete after completion of the 8-week intervention
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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.
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Participants will complete after completion of the 8-week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 24, 2025
Primary Completion (Actual)
July 12, 2025
Study Completion (Actual)
July 12, 2025
Study Registration Dates
First Submitted
March 3, 2025
First Submitted That Met QC Criteria
March 23, 2025
First Posted (Actual)
March 28, 2025
Study Record Updates
Last Update Posted (Actual)
July 30, 2025
Last Update Submitted That Met QC Criteria
July 28, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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
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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