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Recruiting NCT07122843

VR AI Meditation for Pain

No phase Interventional Pain and Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR Guided Meditation.
Who it may be relevant to
Registry conditions: Pain and Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Real Time Guided Meditations for Pain in Virtual Reality Study

Overview

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.

Interventions

  • Device 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 p

Primary outcome measures

  • Pain Numeric Rating Scale Pre and Post VR Guided Meditation [Time frame: Pre VR Use (Baseline) and Post VR Use (after a 15 minutes experience in VR)]
Secondary outcome measures (1)
  • STAI-6 Scores Pre and Post VR Guided Meditation [Time frame: Pre VR use (Baseline) and Post VR use (after 15-minute experience in VR)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cedars-Sinai Medical Center — Los Angeles

Identifiers

NCT: NCT07122843 · STUDY00004263

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗