Virtual Reality After Breast Reconstruction Surgery

NCT03801616 | Terminated Results FDA Device

• 1 other identifier: Pro00055330
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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, administered via VR headsets, to manage pain.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean Difference in Pain

  From operation to discharge, approximately 2 days

• Mean Difference in Length of Stay

  During hospitalization until discharge, approximately 2 days

Study Arms (1)

Virtual Reality

EXPERIMENTAL

Every participant is provided with a VR headset

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Virtual Reality in controlling pain

Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Implant-based reconstruction after mastectomy is not common in males.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Alice Chung
• Organization: Cedars-Sinai Medical Center

alice.chung@cshs.org

3104239331

Study Officials

• Alice Chung, MD

  Cedars-Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: January 30, 2019
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-04

Locations

US (1)