Non-Opioid Pain Management, Pain, Postoperative, Virtual Reality
Conditions
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.
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.
Interventions
DEVICEVirtual Reality
Virtual Reality in controlling pain
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Milligram Equivalents | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Pain | From operation to discharge, approximately 2 days | 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. |
| Mean Difference in Length of Stay | During hospitalization until discharge, approximately 2 days | Length of stay will be collected via hospital records |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Reality Every participant is provided with a VR headset
Virtual Reality: Virtual Reality in controlling pain | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Virtual Reality |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 45.82051 years STANDARD_DEVIATION 11.68866 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: During hospitalization until discharge, approximately 2 days
Population: Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected
Secondary
Mean Difference in Length of Stay
Length of stay will be collected via hospital records
Time frame: During hospitalization until discharge, approximately 2 days
Population: Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected
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.
Time frame: From operation to discharge, approximately 2 days
Population: Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected