Virtual Reality After Breast Reconstruction Surgery

Pain, Postoperative Clinical Trial

— VR4BR  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03801616
• Other study ID #: Pro00055330
• Status: Suspended
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 48
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Virtual Reality
Virtual Reality in controlling pain

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean difference in pain	Pain collected via ecological momentary assessment by hospital staff. Study participants will be asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is "no pain" and 10 is "worst imaginable pain."	From operation to discharge, approximately 2 days
Secondary	Mean difference in length of stay	Length of stay will be collected via hospital records	During hospitalization until discharge, approximately 2 days