Perceived StressNCT06901193
A Virtual Reality Mindfulness-based Intervention for Nurse Managers
A study testing Virtual Reality Mindfulness intervention in people with Perceived Stress and Burnout, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perceived Stress, Burnout, Resilience, Psychological
- What is being tested?
- Virtual Reality Mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 12 Jul 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Conditions
- Perceived Stress, Burnout, Resilience, Psychological, Work Engagement
- Being tested
- Virtual Reality Mindfulness intervention
- Keywords
- mindfulness, virtual reality, nurse, nurse manager
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Mindfulness interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participation in the virtual reality mindfulness intervention the first 8 weeks Receives: Behavioral: Virtual Reality Mindfulness intervention |
| Wait-list control group | Active comparator | will participate in the virtual reality mindfulness intervention during the second 8 weeks of the study Receives: Behavioral: Virtual Reality Mindfulness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
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.
Measured: Baseline and on completion of the 8-week intervention
Maslach Burnout Inventory (MBI-HSS)
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.
Measured: baseline and on completion of the 8-week intervention
Resilience
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.
Measured: baseline and on completion of the 8-week intervention
Work engagement
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.
Measured: baseline and on completion of the 8-week intervention
Respiratory rate
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.
Measured: 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 outcomes (2)
System Usability Scale
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.
Measured: Completed after the 8-week intervention
Feasibility of Intervention Measure
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.
Measured: Participants will complete after completion of the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start24 Feb 2025
- Primary completion12 Jul 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived StressStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Sequential
- Model description
- Intervention, wait-list control
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Steinberg, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901193
- Sponsor's protocol ID
- 2024B0251
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality Mindfulness-based Intervention: The Impact and Acceptability for Nurse Managers in an Academic Medical Center
- ClinicalTrials.gov ID
- NCT06901193
- Acronym / sponsor ID
- 2024B0251
- Conditions
- Perceived Stress, Burnout, Resilience, Psychological, Work Engagement
- Keywords
- mindfulness, virtual reality, nurse, nurse manager
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 28 Mar 2025 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention, wait-list control
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Virtual Reality Mindfulness interventionParticipation in the virtual reality mindfulness intervention the first 8 weeks |
| Wait-list control group | Active comparator | Behavioral: Virtual Reality Mindfulness interventionwill participate in the virtual reality mindfulness intervention during the second 8 weeks of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Virtual Reality Mindfulness interventionMindfulness 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. | Behavioural | Intervention group, Wait-list control group |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
System Usability Scale
Time frame: Completed after the 8-week intervention
Feasibility of Intervention Measure
Time frame: Participants will complete after completion of the 8-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Mindfulness intervention in people with Perceived Stress and Burnout, run by Ohio State University at 1 site in United States.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress (time frame: Baseline and on completion of the 8-week intervention). The study lists 5 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 30 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.