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Virtual Reality for Postoperative Pain After Breast Reconstruction (VR4BR Trial)
N/A
Waitlist Available
Led By Alice Chung, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women who plan to undergo mastectomy and implant-based reconstruction
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from operation to discharge, approximately 2 days
Awards & highlights
VR4BR Trial Summary
This trial will test if VR can help manage pain for women undergoing mastectomy and reconstruction.
Who is the study for?
This trial is for women over 18 who are planning to have a mastectomy and breast reconstruction. They must be able to understand English and follow the study's requirements. It's not for those with certain psychiatric disorders, epilepsy, dementia, sensitivity to flashing lights, motion sickness, frequent nausea or dizziness due to other conditions, or recent opioid use.Check my eligibility
What is being tested?
The study is testing how virtual reality (VR) can help manage pain after breast surgery without using opioids. Participants will use VR headsets that provide specialized programs designed to reduce pain during their recovery process.See study design
What are the potential side effects?
Since this trial involves non-drug therapy with VR, side effects may include discomfort from wearing the headset, eye strain or headache from prolonged screen time. Some might experience disorientation or mild nausea if prone to motion sickness.
VR4BR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Women who plan to have breast removal surgery and use implants for breast reconstruction.
VR4BR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from operation to discharge, approximately 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from operation to discharge, approximately 2 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Morphine Milligram Equivalents
Secondary outcome measures
Mean difference in length of stay
Mean difference in pain
VR4BR Trial Design
1Treatment groups
Experimental Treatment
Group I: Virtual RealityExperimental Treatment1 Intervention
Every participant is provided with a VR headset
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality
2017
Completed Phase 3
~1630
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,809 Total Patients Enrolled
1 Trials studying Postoperative Pain
127 Patients Enrolled for Postoperative Pain
Alice Chung, MDPrincipal InvestigatorCedars-Sinai
2 Previous Clinical Trials
245 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant, or have a condition that makes you feel nauseous or dizzy often.You are sensitive to flashing lights.You have used strong painkillers like opioids in the last 6 months.You have a mental health condition that involves hallucinations or psychosis.Women who plan to have breast removal surgery and use implants for breast reconstruction.You have been diagnosed with motion sickness.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any open slots for participants in this investigation?
"As indicated on clinicaltrials.gov, this medical trial is no longer seeking participants at the moment. The study was first posted in January 2019 and underwent its last update in May 2022. However, there are currently 524 other trials that require patients for their research."
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