Clinical trial NCT05592782: VR Mindfulness Study
Official title: Virtual Reality Mindfulness Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depression
Stress
Pain, Acute
Pain, Chronic
Keywords: Virtual Reality
Anxiety
Depression
Pain
Mood
Mindfulness
Meditation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an exploratory study investigating the use of virtual reality-based guided mindfulness meditation in improving pain, stress, and mood within various clinical populations. The feasibility of utilizing VR applications within the populations of patients with various specific disease types and clinical settings is a burgeoning area of research. The goal is to establish an association between the use of VR-based mindfulness meditation, and pain, stress, and mood scores.

Detailed description: This is a two-center, multi-site exploratory study conducted within the University of California, Los Angeles Health and Greater Los Angeles VA systems. A total of 60 subjects will be recruited. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

Subjects will undergo assessments of stress, depression, anxiety, and pain at baseline, pre- and post-VR guided mediation, and monthly for three months. Each subject can undergo VR-guided meditation session no more than one time per day. In subjects who are hospitalized, an attempt will be made to have the subjects undergo the VR meditation and complete the pre- and post- meditation assessments daily until hospital discharge.

Duration of the study is expected to be 1 year. Each session is expected to last approximately 15 minutes.

Subjects will be given instructions on proper use of the VR devices and how to start the guided meditation software. Once familiar with the device, participants will undergo a guided VR meditation using a commercial VR application. The meditation will last approximately 15 minutes. Prior to starting and on upon completion of each VR meditation session, participants' state pain, anxiety, depression, and stress will be assessed. For each participant enrolled, baseline and monthly assessments using the DASS-21 and PPI-SFI3a will be performed for three consecutive months

Eligibility criteria: Inclusion Criteria:

* Adults at least 18 years old
* Able to read and understand English (Guided meditation software has not yet been translated to languages other than English)

Exclusion Criteria:

* Age \<18 years old
* Unable to speak, read or understand English language
* Blindness or severe hearing impairment
* Any disability or neurological deficit that would impair subject from using the virtual reality console
* Significant movement disorder
* Vertigo and/or motion sickness

Primary outcomes:
measure: Completion of VR Mindfulness Meditation Session
timeFrame: 2 hours
measure: State Anxiety
timeFrame: 2 hours
measure: Pain severity
timeFrame: 2 hours
Secondary outcomes:
measure: Ease of use and acceptability
timeFrame: 2 hours
measure: Depression
timeFrame: 2 hours
measure: Stress
timeFrame: 2 hours
measure: Long term change in Stress, Anxiety, and Depression
timeFrame: 3 months
measure: Long term change in Pain severity
timeFrame: 3 months
measure: Hospital Length of Stay
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Arash Naiem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: