VR Guided Meditation for Pain and Anxiety

Overseen By Ella F Tetrault, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christopher Almario

Disqualifiers: Severe motion sickness, Seizure, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests virtual reality (VR) guided meditation to determine its effectiveness in reducing pain and anxiety in patients. Participants will wear a VR headset and engage in a calming, nature-themed meditation led by an AI guide. The trial aims to assess the effectiveness of this VR approach, gather patient feedback, and identify areas for improvement. Suitable candidates have a pain score of at least 4 out of 10, are admitted to the hospital, and speak English or Spanish. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this VR guided meditation is safe for pain and anxiety management?

Research has shown that using virtual reality (VR) for guided meditation is generally safe for managing pain and anxiety. Studies indicate that VR sessions, which include soothing images and breathing exercises, are easy to handle and have few side effects. For instance, one review found that VR effectively reduced pain in various situations, such as during medical procedures and for ongoing pain. Another study suggested that VR can safely help reduce anxiety and pain, especially in intensive care settings. Overall, these findings suggest that VR could be a safe option for managing pain and anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VR Guided Meditation for pain and anxiety because it offers a unique, immersive experience that differentiates it from traditional treatments like medication or talk therapy. Unlike standard options, this treatment uses a VR headset to transport patients to a calming, virtual environment where an AI guide leads them through personalized meditation. This innovative approach may help patients manage pain and anxiety more effectively by promoting deep relaxation and focus, potentially offering quick relief without the side effects associated with some medications.

What evidence suggests that VR Guided Meditation is effective for pain and anxiety?

Research has shown that virtual reality (VR) for guided meditation can reduce pain and anxiety. One study found that mindfulness techniques using VR greatly improved mindfulness and stress levels, with VR users experiencing more benefits than others. Another study demonstrated that VR sessions significantly lowered anxiety scores, from an average of 19.29 to 9.43. Additionally, VR has proven to be a practical and effective way to manage pain and anxiety, especially for older adults. In this trial, participants will engage in VR-guided meditation, which may help them feel more relaxed and less anxious or in pain. ^{3 5 6 7 8}

Who Is on the Research Team?

Christopher V Almario, MD, MSHPM

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic pain after surgery, or those dealing with pain and anxiety, including anxiety disorders. Participants should be open to using virtual reality (VR) technology for guided meditation as a form of treatment.

Inclusion Criteria

I am 18 years old or older.

Individuals who are admitted to CSMC and who have completed the Inpatient Pain Service Center intake form

I speak either English or Spanish.

Exclusion Criteria

Those who are pregnant

I am willing and able to participate in the study.

Does not understand English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants engage in a 15-minute VR guided meditation session with pre and post-intervention surveys

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain and anxiety levels after the VR session

1 week

What Are the Treatments Tested in This Trial?

Interventions

• VR Guided Meditation

Trial Overview The study tests the effectiveness of VR-guided meditation on reducing pain and anxiety levels. It measures changes before and after the session using specific scales (PNRS & STAI-6) and evaluates how well patients accept this high-tech therapy approach.

How Is the Trial Designed?

Group I: VR Guided Meditation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Christopher Almario

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12260462/

The Effectiveness of Virtual Reality–Based Mindfulness ... The results showed that both interventions led to significant improvements in mindfulness, stress, and affect, with the VR group showing greater ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07122843

Study Details | NCT07122843 | VR AI Meditation for Pain 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), ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0197457225001697

Effects of virtual reality on pain and anxiety in older adults This paper reports findings on the feasibility and efficacy of interventions delivered through VR to reduce pain and/or anxiety among older patients.

4. researchprotocols.org researchprotocols.org/2024/1/e52649

Effectiveness of Virtual Reality in Reducing Perceived Pain ... The purpose of this pilot project is to assess the efficacy of using VR as a distraction-based intervention for anxiety or pain management.

5. uknowledge.uky.edu uknowledge.uky.edu/cgi/viewcontent.cgi?article=1532&context=dnp_etds

Evaluation on the Effectiveness of a Virtual Reality (VR ... Pre-intervention anxiety scores (M = 19.29, SD = 6.82) were significantly higher than post-intervention scores (M = 9.43, SD = 4.89), with a statistically ...

6. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/20552076241308703

The benefits and safety of a virtual reality intervention in ... The selected VR session integrates guided imagery and breathing techniques, designed with the expectation of rapidly reducing pain and anxiety.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10382225/

Virtual reality for pain management: an umbrella review This umbrella review demonstrates successful application of virtual reality in pain control, including perioperative, periprocedural, and chronic pain settings.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0883944125001510

The impact of virtual reality interventions on stress and ... The minimal side effects reported suggest that VR can be a safe adjunct therapy for alleviating anxiety and pain, common issues in ICU settings. For ...