Virtual Reality After Breast Reconstruction Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study

Conditions
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Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Every participant is provided with a VR headset | Device: Virtual Reality<br>* Virtual Reality in controlling pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During hospitalization until discharge, approximately 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From operation to discharge, approximately 2 days | 
| Mean difference in length of stay | Length of stay will be collected via hospital records | During hospitalization until discharge, approximately 2 days |