Virtual Reality After Breast Reconstruction Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-30

Study Completion Date

2020-06-04

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.

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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.

Conditions

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Pain, Postoperative Non-Opioid Pain Management Virtual Reality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual Reality

Every participant is provided with a VR headset

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type DEVICE

Virtual Reality in controlling pain

Interventions

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Virtual Reality

Virtual Reality in controlling pain

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes