NCT06901193

Brief 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. System usability of the VR mindfulness program and integration into the clinical workday will also be assessed for both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 24, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2025

Completed
Last Updated

July 30, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

March 3, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

mindfulnessvirtual realitynursenurse manager

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    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

    Completed after the 8-week intervention

  • Feasibility of Intervention Measure

    Participants will complete after completion of the 8-week intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Participation in the virtual reality mindfulness intervention the first 8 weeks

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

Behavioral: Virtual Reality Mindfulness intervention

Interventions

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.

Intervention groupWait-list control group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Intervention, wait-list control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Research

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 28, 2025

Study Start

February 24, 2025

Primary Completion

July 12, 2025

Study Completion

July 12, 2025

Last Updated

July 30, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF, CSR, ANALYTIC CODE
Time Frame
IPD will be available 10-30-2025 and be accessible indefinitely.
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.

Available IPD Datasets

Study Protocol Access

Locations