NCT03614325

Brief Summary

This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 9, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 4, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 8, 2024

Completed
Last Updated

April 8, 2024

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

July 9, 2018

Results QC Date

June 29, 2021

Last Update Submit

October 13, 2023

Conditions

Anesthesia, IntravenousPain, PostoperativeDelayed Recovery From AnesthesiaSatisfactionRelaxation Therapy

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Propofol Dose

    Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.

    60 minutes

Secondary Outcomes (8)

  • Other Intraoperative Anesthetics or Analgesics Administered

    60 minutes

  • Total Intraoperative Propofol Administered

    60 minutes

  • Length of PACU Stay

    Duration of the patient's stay in the post anesthesia care unit, 100 minutes

  • Pain Assessed by Eleven Point Numerical Rating Scale

    Duration of stay in the post anesthesia care unit, 100 minutes

  • Overall Patient Satisfaction

    PACU discharge

  • +3 more secondary outcomes

Study Arms (2)

Usual Anesthesia Care

NO INTERVENTION

Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.

Virtual Reality Immersive Relaxation

EXPERIMENTAL

Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence.

Other: Virtual Reality Immersive Relaxation

Interventions

Virtual Reality Immersive RelaxationOTHER

The software developed by VRHealth allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.

Virtual Reality Immersive Relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC

You may not qualify if:

  • Age \< 18
  • Open wounds or active infection of the face or eye area
  • History of seizures or other symptom linked to an epileptic condition
  • Patients who plan to wear hearing aids during the procedure
  • Patients with a pacemaker or other implanted medical device
  • Droplet or airborne precautions (as determined by BIDMC infection control policy)
  • Non-English speaking
  • Patients who require deep sedation
  • Patients who are deemed ineligible to approach by the surgeon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Faruki A, Nguyen T, Proeschel S, Levy N, Yu J, Ip V, Mueller A, Banner-Goodspeed V, O'Gara B. Virtual reality as an adjunct to anesthesia in the operating room. Trials. 2019 Dec 27;20(1):782. doi: 10.1186/s13063-019-3922-2.

    PMID: 31882015DERIVED

MeSH Terms

Conditions

Pain, PostoperativeDelayed Emergence from AnesthesiaPersonal Satisfaction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsBehavior

Results Point of Contact

Title
Dr. Brian P. O'Gara
Organization
Beth Israel Deaconess Medical Center
bpogara@bidmc.harvard.edu
6177543189

Study Officials

  • Brian O'Gara, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist, Principal Investigator

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 3, 2018

Study Start

December 4, 2018

Primary Completion

November 7, 2019

Study Completion

June 1, 2021

Last Updated

April 8, 2024

Results First Posted

April 8, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)