Virtual Reality After Breast Reconstruction Surgery (VR4BR)
Primary Purpose
Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Reality
Arm Description
Every participant is provided with a VR headset
Outcomes
Primary Outcome Measures
Morphine Milligram Equivalents
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
Mean difference in pain
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."
Mean difference in length of stay
Length of stay will be collected via hospital records
Full Information
NCT ID
NCT03801616
First Posted
January 8, 2019
Last Updated
June 15, 2023
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03801616
Brief Title
Virtual Reality After Breast Reconstruction Surgery
Acronym
VR4BR
Official Title
VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Every participant is provided with a VR headset
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
Virtual Reality in controlling pain
Primary Outcome Measure Information:
Title
Morphine Milligram Equivalents
Description
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.
Time Frame
During hospitalization until discharge, approximately 2 days
Secondary Outcome Measure Information:
Title
Mean difference in pain
Description
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."
Time Frame
From operation to discharge, approximately 2 days
Title
Mean difference in length of stay
Description
Length of stay will be collected via hospital records
Time Frame
During hospitalization until discharge, approximately 2 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Implant-based reconstruction after mastectomy is not common in males.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Chung, MD
Organizational Affiliation
Cedars-Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Virtual Reality After Breast Reconstruction Surgery
We'll reach out to this number within 24 hrs