Pain, PostoperativeVR4BRNCT03801616
Virtual Reality After Breast Reconstruction Surgery
A study testing Virtual Reality in people with Pain, Postoperative and Non-Opioid Pain Management, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2019to 4 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study
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.
Read the 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.
- Being tested
- Virtual Reality
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual Reality in controlling pain
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Every participant is provided with a VR headset Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hospitalization until discharge, approximately 2 days
Secondary outcomes (2)
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."
Measured: From operation to discharge, approximately 2 days
Mean Difference in Length of Stay
Length of stay will be collected via hospital records
Measured: During hospitalization until discharge, approximately 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start30 Jan 2019
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Why it stopped: Due to the COVID-19 virus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Chung, Cedars-Sinai Medical Center
- Investigators
- Alice Chung, MD, Principal investigator, Cedars-Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801616
- Sponsor's protocol ID
- Pro00055330
- Acronym
- VR4BR
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2019
- Last updated
- 1 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study
- ClinicalTrials.gov ID
- NCT03801616
- Acronym / sponsor ID
- VR4BR / Pro00055330
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 virus
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 1 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityEvery participant is provided with a VR headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityVirtual Reality in controlling pain | Device | Virtual Reality |
Primary outcome
Morphine Milligram Equivalents
Time frame: During hospitalization until discharge, approximately 2 days
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.
2 secondary outcomes
Mean Difference in Pain
Time frame: From operation to discharge, approximately 2 days
Mean Difference in Length of Stay
Time frame: During hospitalization until discharge, approximately 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Chung, MD principal investigator
Cedars-Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Pain, Postoperative and Non-Opioid Pain Management, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Milligram Equivalents (time frame: During hospitalization until discharge, approximately 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.