VR AI Meditation for Pain

ConditionPain and Anxiety

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorChristopher Almario

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

38 Participants

are divided into 1 treatment group

Group A: VR Guided MeditationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

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

Secondary outcomes

STAI-6 Scores Pre and Post VR Guided Meditation

To evaluate anxiety scores pre and post VR guided meditation on the STAI-6.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christopher Almario

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Source ClinicalTrials.gov

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