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Due to the COVID-19 virus
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | Every participant is provided with a VR headset |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | Virtual Reality in controlling pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Implant-based reconstruction after mastectomy is not common in males.
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| Name | Affiliation | Role |
|---|---|---|
| Alice Chung, MD | Cedars-Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality | Every participant is provided with a VR headset Virtual Reality: Virtual Reality in controlling pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality | Every participant is provided with a VR headset Virtual Reality: Virtual Reality in controlling pain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected | Posted | During hospitalization until discharge, approximately 2 days |
|
NA - Adverse Events not collected for this study.
Study suspended for COVID-19 and did not re-start; no funding available to analyze the data
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality | Every participant is provided with a VR headset Virtual Reality: Virtual Reality in controlling pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alice Chung | Cedars-Sinai Medical Center | 3104239331 | alice.chung@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2018 | Feb 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Mean Difference in Length of Stay |
Length of stay will be collected via hospital records |
| During hospitalization until discharge, approximately 2 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 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." | Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected | Posted | From operation to discharge, approximately 2 days |
|
|
| Secondary | Mean Difference in Length of Stay | Length of stay will be collected via hospital records | Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected | Posted | During hospitalization until discharge, approximately 2 days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |