NCT03801616

Virtual Reality After Breast Reconstruction Surgery

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Virtual Reality	Virtual Reality in controlling pain

Timeline

• Start date: 2019-01-30
• Primary completion: 2020-06-04
• Completion: 2020-06-04
• First posted: 2019-01-11
• Last updated: 2025-05-01
• Results posted: 2025-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study