Virtual Reality After Breast Reconstruction Surgery

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Virtual Reality	Every participant is provided with a VR headset

Primary Outcome Measures

Name	Time	Method
Morphine Milligram Equivalents	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

Name	Time	Method
Mean Difference in Pain	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	During hospitalization until discharge, approximately 2 days	Length of stay will be collected via hospital records