The Role of Virtual Reality During Regional Anesthesia

Pain Clinical Trial

Official title:

The Role of Virtual Reality During Regional Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04163809
• Other study ID #: Pro00055672
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Cedars-Sinai Medical Center
• Contact: Janelle Burskey, RN
• Phone: 310-423-9600
• Email: janelle.burskey[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. Elective pre-operative patients at Cedars-Sinai Medical Center who are receiving regional anesthesia

2. Between ages 18-64

3. Patient must be able to provide informed consent

Exclusion Criteria:

1. Patients under the age of 18 & above age 64

2. Visual impairment

3. Pregnant women

4. Diagnosis of epilepsy/seizures, dementia, and/or cognitive impairment

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Device:
• Virtual Reality with Oculus Go headset
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.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Level Prior to Regional Anesthesia	questionnaire to rate anxiety on a scale of 0-10	questionnaire given within 1 hour prior to regional anesthesia procedure
Primary	Anxiety Level During Regional Anesthesia	questionnaire to rate anxiety on a scale of 0-10	questionnaire given within 1 hour after regional anesthesia procedure
Primary	Pain Level Prior to Regional Anesthesia	questionnaire to rate pain on a scale of 0-10	questionnaire given within 1 hour prior to regional anesthesia procedure
Primary	Pain Level During Regional Anesthesia	questionnaire to rate pain on a scale of 0-10	questionnaire given within 1 hour after regional anesthesia procedure