Virtual Reality After Breast Reconstruction Surgery (VR4BR)

Cedars-Sinai Medical Center

Status: Terminated

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

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT03801616

Pro00055330

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Virtual Reality

Experimental group

Description:

Every participant is provided with a VR headset

Treatment:

Device: Virtual Reality