跳至主要内容
临床试验/NCT07122843
NCT07122843招募中不适用

Real Time Guided Meditations for Pain in Virtual Reality Study

Christopher Almario1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
38
试验地点
1
主要终点
Pain Numeric Rating Scale Pre and Post VR Guided Meditation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: VR Guided Meditation (Device)

结局指标

主要结局

Pain Numeric Rating Scale Pre and Post VR Guided Meditation

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

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).

次要结局

  • STAI-6 Scores Pre and Post VR Guided Meditation(Pre VR use (Baseline) and Post VR use (after 15-minute experience in VR))

研究者

发起方
Christopher Almario
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christopher Almario

Associate Professor of Medicine

Cedars-Sinai Medical Center

研究点 (1)

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