Virtual Reality After Breast Reconstruction Surgery (VR4BR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03801616
Recruitment Status : Active, not recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Information provided by (Responsible Party):
Alice Chung, MD, Cedars-Sinai Medical Center

Brief Summary:
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction. Study participants will receive specialized VR interventions, administered via VR headsets, to manage pain.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Non-Opioid Pain Management Virtual Reality Device: Virtual Reality Not Applicable

Detailed Description:

The primary objective of this study is to estimate the effect of utilizing VR on reducing opioid use in study participants undergoing mastectomy with implant-based reconstruction compared to the control group. Investigators will follow patients throughout the course of their hospitalization and monitor outcomes including pain levels, medication requests, and satisfaction.

Eligible participants will receive a VR headset and instructed to use the VR every time they feel pain and before asking for a pain medication. They can take pain medications, if they choose to do so. At their post-op visit, study participants will be interviewed and asked questions regarding their experience with VR.

Pain level and medication use will be compared with similar individuals who undergo the same procedure but are not provided with a VR headset.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Virtual Reality
Every participant is provided with a VR headset
Device: Virtual Reality
Virtual Reality in controlling pain

Primary Outcome Measures :
  1. Morphine Milligram Equivalents [ Time Frame: During hospitalization until discharge, approximately 2 days ]
    Opioid usage is defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription.

Secondary Outcome Measures :
  1. Mean difference in pain [ Time Frame: From operation to discharge, approximately 2 days ]
    Pain collected via ecological momentary assessment by hospital staff. Study participants will be asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is "no pain" and 10 is "worst imaginable pain."

  2. Mean difference in length of stay [ Time Frame: During hospitalization until discharge, approximately 2 days ]
    Length of stay will be collected via hospital records

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Implant-based reconstruction after mastectomy is not common in males.
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age ≥ 18 years
  • Women who plan to undergo mastectomy and implant-based reconstruction
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  • Able to read and comprehend English

Exclusion Criteria:

  • Current diagnosis of epilepsy, dementia, or other neurologic disease that may prevent use of VR headset and software
  • Sensitivity to flashing light
  • Diagnosis of motion sickness
  • Pregnancy or a medical condition where the study participant is prone to frequent nausea or dizziness
  • Current or recent (less than 6 months) use of opioids
  • Individuals with psychiatric disorders, including those with delirium or other disorders that may involve hallucinations or psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03801616

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Principal Investigator: Alice Chung, MD Cedars-Sinai

Responsible Party: Alice Chung, MD, Assistant Professor of Surgery, Cedars-Sinai Medical Center Identifier: NCT03801616     History of Changes
Other Study ID Numbers: Pro00055330
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms