Status:
TERMINATED
Virtual Reality After Breast Reconstruction Surgery
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Pain, Postoperative
Non-Opioid Pain Management
Eligibility:
FEMALE
18+ years
Phase:
NA
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, admi...
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 contr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03801616
Start Date
January 30 2019
End Date
June 4 2020
Last Update
May 1 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048