Healing Hearts of Hospitalized Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorStanford University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe cognitive impairment
Clinically unstable
Facial trauma prohibiting headset use
Physical limitations in facial, neck, upper extremities that hinder use of VR equipment
Trial design
Design model
Crossover
Treatments tested in this trial
VR mindfulness application
BehavioralParticipants 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.
Standard of Care (SOC)
BehavioralParticipants 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: VR GroupExperimental treatment 2 interventions
Group B: Standard of CareActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Mental Well-being
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
Time frame
baseline, immediately after the interventionSecondary outcomes
1
STAI-Trait
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.
Time frame
Baseline2
Change in STAI-State
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.
Time frame
Baseline, immediately after the intervention3
Change in Positive and Negative Affect Schedule (PANAS)
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)
Time frame
baseline, immediately after the intervention4
Change in Relaxation State measured by the Relaxation State Questionnaire (RSQ)
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.
Time frame
baseline, immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov