Affect, Anxiety, Relaxation, Well-Being, Psychological
Conditions
Keywords
Virtual Reality
Brief summary
The study aims to evaluate the impact of a bedside-delivered virtual reality (VR) mindfulness experience on well-being and psychosocial outcomes among hospitalized adult patients compared to standard of care (SOC; no added mindfulness intervention).
Interventions
BEHAVIORALVR mindfulness application
Participants receiving the VR intervention will be instructed to wear a Meta Quest 2 headset (Meta, Inc., Menlo Park, CA) and participate in a VR mindfulness application that is specifically designed to promote mindfulness, relaxation, and emotional regulation via guided content delivered in an immersive environment. Participants will be asked to complete pre and post intervention surveys.
BEHAVIORALStandard of Care (SOC)
Participants will undergo a 30-minute SOC window during which they will be asked to do whatever they would normally do for relaxation during hospitalization. Participants will be asked to complete pre and post intervention surveys.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and above * Able to provide informed consent * Able to follow verbal instructions * Adequate motor skills for upper extremities to operate VR equipment * Clinically stable * English speaking * Willing to participate in mindfulness activities
Exclusion criteria
* Severe cognitive impairment * Clinically unstable * Facial trauma prohibiting headset use * Physical limitations in facial, neck, upper extremities that hinder use of VR equipment * History of seizures or other neurological conditions * Severe motion sickness * Active nausea * Severe visual impairment * Severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mental Well-being | baseline, immediately after the intervention | The World Health Organization - Five Well-Being Index (WHO-5) is a participant-reported outcome measure that assesses current mental well being. Questionnaire contains 5 questions. It scores five positively phrased items from 0 ("at no time") to 5 ("all of the time"), with a total raw score of 0-25, where lower scores indicate poorer well-being |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| STAI-Trait | Baseline | The State-Trait Anxiety Inventory - Trait (STAI-T) is a 20-item self-report questionnaire measuring long-standing, stable anxiety tendencies. It is a 4-point Likert scale, ranging from 20-80, with higher scores indicating higher anxiety. |
| Change in STAI-State | Baseline, immediately after the intervention | The State-Trait Anxiety Inventory - State (STAI-S) is a 20-item self-report tool used to measure current, transient anxiety states. It is a 4-point Likert scale, ranging from 20-80, with higher scores indicating higher anxiety. |
| Change in Positive and Negative Affect Schedule (PANAS) | baseline, immediately after the intervention | The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire (10 positive, 10 negative) used to measure emotional state and affect regulation. It is a 5-point Likert scale (1 = Very Slightly/Not at All; 5 = Extremely) |
| Change in Relaxation State measured by the Relaxation State Questionnaire (RSQ) | baseline, immediately after the intervention | the Relaxation State Questionnaire (RSQ; Steghaus \& Poth, 2022) is a validated 10-item self-report instrument measuring momentary subjective relaxation states across four subscales: Muscle Scale, Cardiovascular Scale, General Relaxation Scale, and Sleepiness Scale. Each item is rated on a 5-point Likert scale (1 = Not correct at all to 5 = Entirely correct), with reverse-scored items as indicated. |
| Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey | immediately after the intervention | Participants will complete the Self-Developed Satisfaction survey. The instrument includes 4 closed-ended items with varying response formats. Three question is on a 5-point Likert scale (1 = Not at all, 5=Completely) and one is in "Check all that apply" format. |
Countries
United States
Contacts
CONTACTThomas Caruso, MD, PhD
CONTACTMan Yee Suen, MD
Outcome results
None listed