VR AI Meditation for Pain

NCT07122843 | Recruiting FDA Device

• 1 other identifier: STUDY00004263
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess changes in pain and anxiety as reported by the Pain Numeric Rating Scale (PNRS) and the State-Trait Anxiety Inventory 6 (STAI-6), pre and post a guided meditation in Virtual reality. Objectives of the study are also to determine the feasibility, and patient acceptance of utilizing a LLM-generated guided meditation in VR. Our goal is to learn about any limitations of our approach and provide a pathway for future improvements in creating a VR AI therapist that is optimally aligned with the needs of users.

Conditions

Pain and Anxiety

Keywords

Virtual Reality; Meditation; Guided Meditation

Outcome Measures

Primary Outcomes (1)

• Pain Numeric Rating Scale Pre and Post VR Guided Meditation

  To evaluate impact to pain levels after VR guided meditation (1 time). We will use a validated pain survey and look at Pain Numeric Rating Scale (pre compared to post-VR).

  Pre VR Use (Baseline) and Post VR Use (after a 15 minutes experience in VR)

Secondary Outcomes (1)

• STAI-6 Scores Pre and Post VR Guided Meditation

  Pre VR use (Baseline) and Post VR use (after 15-minute experience in VR)

Study Arms (1)

VR Guided Meditation

EXPERIMENTAL

Patients will wear a VR headset for approximately 15 minutes. The headset fully covers the eyes, immersing users in a calming, 3D virtual environment. Once the headset is on, patients will engage in a guided meditation experience, set in a nature-themed scene of their choice; options include a lake, beach, mountains, desert, forest, space, and more. An AI-powered guide will lead the meditation, offering real-time, personalized support based on the patient's age and the pain-related information provided during the hospital intake process. The AI is designed to promote relaxation by helping patients focus, breathe deeply, and feel more at ease. The intervention will be standardized for all participants, with each receiving the same duration of exposure in the VR headset and access to an identical selection of nature scenes. The patients will fill our pre and post intervention pain and anxiety surveys. The pre and post surveys will take between 5-10 minutes each to complete.

Device: VR Guided Meditation

Interventions

VR Guided Meditation DEVICE

Patients will wear a VR headset for approximately 15 minutes. The headset fully covers the eyes, immersing users in a calming, 3D virtual environment. Once the headset is on, patients will engage in a guided meditation experience, set in a nature-themed scene of their choice; options include a lake, beach, mountains, desert, forest, space, and more. An AI-powered guide will lead the meditation, offering real-time, personalized support based on the patient's age and the pain-related information provided during the hospital intake process. The AI is designed to promote relaxation by helping patients focus, breathe deeply, and feel more at ease. The intervention will be standardized for all participants, with each receiving the same duration of exposure in the VR headset and access to an identical selection of nature scenes. The patients will fill our pre and post intervention pain and anxiety surveys. The pre and post surveys will take between 5-10 minutes each to complete.

VR Guided Meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Individuals who are admitted to CSMC and who have completed the Inpatient Pain Service Center intake form.
• Participants must speak one of the program's supported languages (currently English and Spanish)
• Minimum pain score of 4 out 10 on baseline pain survey

You may not qualify if:

• Unwilling and/or unable to participate
• Does not understand English or Spanish
• Self-reported history of severe motion sickness
• The presence of a facial/head deformity that will prohibit the wearing of a VR HMD
• Those that require corrective lenses -2.5 or stronger that cannot be corrected with contact lenses
• Legally deaf
• Having had a seizure in the past year
• Unable to understand the instructions or to consent to participation in the study
• Those who are pregnant

Sponsors & Collaborators

• Christopher Almario: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Christopher V Almario, MD, MSHPM

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ella F Tetrault, BS

CONTACT

4243151311; ella.tetrault@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-09

Locations

US (1)