NCT04163809

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
0mo left

Started Jan 2020

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

November 3, 2019

Last Update Submit

May 12, 2025

Conditions

AnxietyPain

Keywords

virtual realityanxietypainregional anesthesia

Outcome Measures

Primary Outcomes (4)

  • 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

  • Anxiety Level During Regional Anesthesia

    questionnaire to rate anxiety on a scale of 0-10

    questionnaire given within 1 hour after regional anesthesia procedure

  • 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

  • Pain Level During Regional Anesthesia

    questionnaire to rate pain on a scale of 0-10

    questionnaire given within 1 hour after regional anesthesia procedure

Study Arms (2)

Control Group (no VR)

NO INTERVENTION

Patients will be randomly allocated to the control group, which receives no Virtual Reality (VR) during the regional anesthesia procedure.

Experimental Group (VR)

EXPERIMENTAL

Patients will be randomly allocated to the the experimental group, which receives VR during the regional anesthesia procedure.

Device: Virtual Reality with Oculus Go headset

Interventions

Virtual Reality with Oculus Go headsetDEVICE

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.

Also known as: Oculus Go
Experimental Group (VR)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 5320816BACKGROUND

  • 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.

    PMID: 15745448BACKGROUND

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

    PMID: 6399756BACKGROUND

  • 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.

    PMID: 27171578BACKGROUND

  • 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.

    PMID: 21779307BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary Vijjeswarapu, MD

    CSMC Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janelle Burskey, RN

CONTACT

310-423-9600janelle.burskey@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 3, 2019

First Posted

November 15, 2019

Study Start

January 27, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)