VR Mindfulness Study

Depression Clinical Trial

Official title:

Virtual Reality Mindfulness Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05592782
• Other study ID #: IRB#22-001517
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: October 2023

Study information

• Verified date: October 2022
• Source: University of California, Los Angeles
• Contact: Herman Davidovics, MD
• Phone: 323-649-5155
• Email: hdavidovics[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Chronic Pain
• Depression
• Pain, Acute
• Pain, Chronic
• Stress

Intervention

Behavioral:
• Virtual Reality Based Mindfulness meditation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of VR Mindfulness Meditation Session	Proportion of subjects able to complete VR meditation sessions	2 hours
Primary	State Anxiety	Change in STAI-6 scores pre- and post-use of VR meditation application	2 hours
Primary	Pain severity	Change in VAS-100 scores pre- and post-use of VR meditation application	2 hours
Secondary	Ease of use and acceptability	Modified User Satisfaction Evaluation Questionnaire scores after each session	2 hours
Secondary	Depression	Change in BDI-SF scores pre and post-use of VR meditation	2 hours
Secondary	Stress	Change in SSSQ scores pre- and post-use of VR meditation	2 hours
Secondary	Long term change in Stress, Anxiety, and Depression	Change in DASS-21 scores monthly for 3 months	3 months
Secondary	Long term change in Pain severity	Change in PROMIS Pain Intensity- Short Form 3a scores over 3 months	3 months
Secondary	Hospital Length of Stay	Compare subject length of stay in hospital to average length of stay for admission diagnosis	4 months