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AnxietyNCT04163809

The Role of Virtual Reality During Regional Anesthesia

A study testing Virtual Reality with Oculus Go headset in people with Anxiety and Pain, run by Cedars-Sinai Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In this study, we will analyze the role of virtual reality in acute pain and anxiety management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical Center. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Pain
What is being tested?
Virtual Reality with Oculus Go headset
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
1 Jan 2027to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Elective pre-operative patients at Cedars-Sinai Medical Center who are receiving regional anesthesia
  • Between ages 18-64
  • Patient must be able to provide informed consent

Who cannot join

  • Patients under the age of 18 \& above age 64
  • Visual impairment
  • Pregnant women
  • Diagnosis of epilepsy/seizures, dementia, and/or cognitive impairment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Janelle Burskey, RN contact

310-423-9600

janelle.burskey@cshs.org

United States1 site

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Janelle Burskey, 310-423-9600

Other trials in United States

About this study

In this study, we will analyze the role of virtual reality in acute pain and anxiety management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical Center.

Read the detailed description

Virtual reality (VR) is a technology that allows people to be immersed in an artificial 3D environment with visual and auditory stimulation. Recently, VR technology has been integrated into medical practices and used during multi-modal pain management. The purpose of this study is to analyze the role of VR in acute pain and anxiety management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical Center (CSMC). Little is known about the role of virtual reality during regional anesthesia. Patients who volunteer to be apart of this study will be randomly assigned to one of two groups: one that receives VR (experimental group) and one that does not receive VR (control group) during the regional anesthesia procedure. Those who wear the Oculus Go virtual reality headset will view pleasant, distracting scenes. Patients that are included in the study must be between 18-64 years of age, pre-operative at CSMC, receiving regional anesthesia, and able to provide informed consent. No further follow up is required. Traditionally, pre-operative patients at CSMC do not have the option of wearing the VR apparatus during nerve block procedures, and some patients may receive pre-medications before nerve blocks. Those enrolled in the study will not receive pre-medication. Before and after the procedure, the patients will receive a brief questionnaire that will be used to determine if virtual reality can be an efficacious tool in reducing pain and anxiety during regional anesthesia. All data collection and storage will be at CSMC. If VR is found to have a statistically significant reduction of acute pain compared to the control group, we can offer VR to patients to help alleviate acute pain, discomfort, and anxiety during regional anesthesia procedures.

Conditions
Anxiety, Pain
Being tested
Virtual Reality with Oculus Go headset
Keywords
virtual reality, anxiety, pain, regional anesthesia
Medical subject headings
Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality with Oculus Go headsetDevice

    Also called Oculus Go

    The investigator will place the Oculus Go VR headset on the patient. VR will provide distracting, pleasant visual stimulus from the beginning of the procedure (while the patient is being cleaned and draped) and removed immediately after the regional anesthesia procedure is complete for roughly 10-20 minutes. All patients receiving VR will view the same scene.

Study groups in NCT04163809
Study groupRoleWhat they receive
Control Group (no VR)No interventionPatients will be randomly allocated to the control group, which receives no Virtual Reality (VR) during the regional anesthesia procedure.
Experimental Group (VR)ExperimentalPatients will be randomly allocated to the the experimental group, which receives VR during the regional anesthesia procedure.
Receives: Device: Virtual Reality with Oculus Go headset

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety Level Prior to Regional Anesthesia

    questionnaire to rate anxiety on a scale of 0-10

    Measured: questionnaire given within 1 hour prior to regional anesthesia procedure

  2. Anxiety Level During Regional Anesthesia

    questionnaire to rate anxiety on a scale of 0-10

    Measured: questionnaire given within 1 hour after regional anesthesia procedure

  3. Pain Level Prior to Regional Anesthesia

    questionnaire to rate pain on a scale of 0-10

    Measured: questionnaire given within 1 hour prior to regional anesthesia procedure

  4. Pain Level During Regional Anesthesia

    questionnaire to rate pain on a scale of 0-10

    Measured: questionnaire given within 1 hour after regional anesthesia procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2019
  2. Study start1 Jan 2027 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04163809
Sponsor's protocol ID
Pro00055672
Status last verified
May 2026
First submitted
3 Nov 2019
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

    PubMed 5320816

  • Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.

    PubMed 15745448

  • McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516-33. No abstract available.

    PubMed 6399756

  • Sharar SR, Alamdari A, Hoffer C, Hoffman HG, Jensen MP, Patterson DR. Circumplex Model of Affect: A Measure of Pleasure and Arousal During Virtual Reality Distraction Analgesia. Games Health J. 2016 Jun;5(3):197-202. doi: 10.1089/g4h.2015.0046. Epub 2016 May 12.

    PubMed 27171578

  • Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.

    PubMed 21779307

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality with Oculus Go headset in people with Anxiety and Pain, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janelle Burskey, RN (310-423-9600, janelle.burskey@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety Level Prior to Regional Anesthesia (time frame: questionnaire given within 1 hour prior to regional anesthesia procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04163809, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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