VR AI Meditation for Pain

NCT ID: NCT07122843

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-06
• Study Completion Date: 2027-01-20

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.

Detailed Description

38 individuals who are admitted to CSMC, who have completed Inpatient Pain Service Center intake form, and who have a baseline pain score of 4 on the PNRS or greater to experience VR guided meditation will be invited to join the study. Patients must have a minimum baseline pain score of 4 or higher on the PNRS to be eligible for evaluation in this study because if a patient begins with no or minimal pain, there is no opportunity for the VR meditation program to produce a measurable reduction in pain levels. 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. Participants will complete pre-intervention pain and anxiety surveys which will take 5-10 minutes followed by a 15-minute experience in VR and we will end with a post-intervention pain (PNRS) and anxiety (STAI-6) surveys (5-10 minutes). The total session will range from 25-35 minutes in length. The study is also determine the feasibility, and patient acceptance of utilizing a LLM-generated guided meditation in VR. The 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR Guided Meditation

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.

Group Type: EXPERIMENTAL

VR Guided Meditation

Intervention Type: 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.

Interventions

VR Guided Meditation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18+ 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christopher Almario

OTHER

Sponsor Role: lead

Responsible Party

Christopher Almario

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christopher V Almario, MD, MSHPM

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ella F Tetrault, BS

Role: CONTACT

ella.tetrault@cshs.org

4243151311

Facility Contacts

Ella F Tetrault, BS

Role: primary

ella.tetrault@cshs.org

4243151311

Other Identifiers

STUDY00004263

Identifier Type: -

Identifier Source: org_study_id