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.|
|ClinicalTrials.gov Identifier: NCT03801616|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Non-Opioid Pain Management Virtual Reality||Device: Virtual Reality||Not Applicable|
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|
Experimental: Virtual Reality
Every participant is provided with a VR headset
Device: Virtual Reality
Virtual Reality in controlling pain
- 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.
- 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."
- Mean difference in length of stay [ Time Frame: During hospitalization until discharge, approximately 2 days ]Length of stay will be collected via hospital records
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 ClinicalTrials.gov identifier (NCT number): NCT03801616
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Alice Chung, MD||Cedars-Sinai|