Virtual Reality for Postoperative Pain After Laparoscopic Hysterectomy

According to the CDC, 115 Americans die every day due to opioid overdose. Prescription opioid
related overdose deaths accounted for 40% of all opioid deaths in the US in 2016. In surgery,
opioids are an effective tool in reducing pain in the postoperative state. However, this may
lead to dependence if pain control is poorly managed. A study examining analgesic use after
low risk surgery found that patients requiring a second prescription for opioids within 7
days of their surgery were 44% more likely to become long-term opioid users one year after
their surgery.

n order to combat this issue, the concept of multi-modal analgesia has been promoted to
reduce the use of opioids for postoperative pain. This modality includes medications (e.g.
NSAIDS), regional anesthesia, and adjunct therapies such as meditation and acupuncture.

Virtual reality (VR) is an emerging technology in which a person is immersed in an
environment through visual and audio cues that effect the senses. These effects can lead to
all types of reactions based on the content and as such, virtual reality is used as a
platform for, amongst other things, entertainment, education and patient care.

In health care, virtual reality has been used to desensitize patients with various phobias,
provide surgical training and as an effective tool for pain control. At this time, there are
no studies demonstrating the use of virtual reality for pain control after gynecologic
surgery.

This is a feasibility study to asses if VR can be used for postoperative pain control and
whether a VR relaxation program used in the immediate post operative period after
laparoscopic hysterectomy will decrease pain scores and reduce both oral and intravenous
opioid consumption. If this study is feasible the investigators would then be able to perform
a larger study, which could show if VR does or does not reduce postoperative pain. Possible
benefits from this study include improved pain control requiring less narcotic medications
during the time spent in the PACU after laparoscopic hysterectomy for benign indication. It
could also provide improvement of anxiety associated with the postoperative period. This
intervention could be a benefit for all women who desire to use non-pharmacologic measures
for pain control during the immediate postoperative period. Alternatively, the patient can
proceed without the intervention if desired. There are many other pain control methods that
the patient can still use during the study. Nothing will be withheld from the patient due to
the study.

Recruitment will take place in the outpatient clinic and the preoperative area of the Main
Operating Room or Same Day Surgery Once a potential study patient has been identified, a
written informed consent form will be provided by a member of the research team to the
patient. The member of the team will review the consent form with the patient and she will
have the opportunity then to chose to voluntarily participate or decline with the
understanding, should she decline, this will in no way affect her care. After all her
questions have been answered and she elects to participate in the study, she will sign the
consent and a signed copy of the consent will be provided to her for her records. This will
be at not cost to the subjects.

Risks include exacerbation of claustrophobia, anxiety, nausea, vomiting due to how the VR
works. There are very few risks associated with the intervention. There is a 0.025% risk of
seizures, particularly in patients with a known seizure disorder. Theoretically patients with
claustrophobia could have exacerbated symptoms, however, these symptoms have not been seen
and recorded. Patients with these risk factors will be excluded from the study. There is
another theoretical risk of increased nausea, although this has not been shown to occur in
previous studies site them.

Our exclusion criteria helps to reduce the possibility of adverse effects from experiencing
VR. Once consent forms are signed, they will be kept in a locked drawer of the fellow
involved. All data will be collected via RED cap, which is a secure website. When the patient
is randomized, they will be given a subject number. This will be used to de-identify the
patient.

Adverse events/reactions will be reported to the UA IRB. In the case of injury or illness
resulting from this study, emergency medical treatment is available from Banner University
Medical Center Phoenix but will be provided at the usual charge. No funds have been set aside
to compensate the participant in the event of injury. Their insurance company will be charged
for continuing medical care and/or hospitalization.

To assure their study-related costs are paid for, all study-related procedures/tests must be
conducted at a Banner Health facility.

he data collection sheets will be stored in the fellows office (Room 3113, 1441 N 12th St.
Phoenix, AZ 85006). Information from these forms, and demographic data collected from the
patient's chart will be stored in REDcap and only be accessible by members of the study.

Subjects can decide to be removed from the study at any time from when they first consent to
the study to when they fill out the survey at the two week postoperative visit. Their
withdrawal will be noted in RED cap. The paper forms used to collect data will be destroyed
and their virtual data collection sheets will be deleted from REDCap.

All consents will be done in either private exam rooms within the Women's Institute clinic in
the 1441 Building of Banner University Medical Center or the private preoperative bay on the
day of surgery. Only those involved in consenting and data collection will be allowed to
access the consent forms and place data in REDCap.

The patient would be committed to the study during the postoperative recovery period in the
PACU, which is approximately 4 hours. They will also be asked to complete a brief survey at
the time of their 2 week postoperative visit. If not, they will be mailed the survey to
complete and return.

The control group will have no changes to routine PACU protocol. They will be asked to rate
their pain at defined intervals that can later be compared to the pain scores of the
intervention group. Morphine equivalents during PACU stay will be calculated for the control
group. The intervention group will also be offered the routine PACU protocol. The only change
being the addition of offering the VR intervention which includes the Samsung VR Innovator
edition goggle set, fitted with Samsung Galaxy Note 4 mobile phone. The module options are
provided from Applied VR and include Guided relaxation (30 minutes), a tour of Iceland (3
minutes), Dream Beach (30 minutes), Dolphin Swim (15 minutes), Farm Sanctuary (5 minutes),
Seal Hospital (10 minutes), and Wild West (5 minutes).

Prior to each new subject use, fabric surfaces of the Samsung Gear set will be cleaned with
VIrex, Sani-Wipes will be used to clean the plastic housing, and the glass lenses will be
cleaned with an alcohol-based lens cleaner. Each headset will be fitted with a sanitary
disposable fabric cover on the VR goggles for new users. Each subject will also wear fitted
head caps that minimize direct contact with the devices. At time of recruitment, patients
will be given the opportunity to try on the VR goggles and watch the four chosen VR modules
that will be offered during their PACU recovery period. At that time, subjects will be
instructed on how to apply the head gear. Subjects will apply and remove the headgear
themselves, while their trained PACU nurses will be able to assist them in adjusting head
straps once the VR goggles have been placed. Subjects will be able to discontinue use of the
VR goggles at any time they wish, including before the conclusion of their chosen VR module.
There is no minimum or maximum amount of time patients will be allotted to participate in VR
modules during their PACU stay. The total amount of time using the VR system and number of
separate uses will be recorded. After each patient completes the study, the disposable head
cap, fabric covers and foam backing from the devices will be discarded.

It is routine for patients to follow up two weeks after their surgery for a postoperative
visit. At that time, they will be asked to complete a survey addressing their satisfaction
with the postoperative recovery process in the PACU. If they are not seen in 2 weeks, the
survey will be mailed, or the subjects will be contacted via phone to complete the survey.

Up to 30 patients will be recruited for this pilot study. A Master Log will be created that
includes patient ID number, patient name, MRN, and date of surgery. The data collection form
will be created that includes patient ID number, age, height, weight, BMI, VR Y/N,
preoperative diagnosis, past medical history, ASA classification, initial pain score, final
pain score, total morphine equivalents used during post-anesthesia recovery unit (PACU) stay,
length of time from admission to discharge from PACU, number of uses of VR, total VR use
time, and other medications given also include if/when local analgesic was used, what type
and where. RedCap is an online data tool that will be used as to collect and store data. At
the end of the study, the Master Log, which will be the only document containing patient
identifiers will be destroyed.

A review of the study will be performed half way through the process (when 15 subjects have
participated) to assess the safety of the study. The investigators will assess how many, if
any, of the participants in the study had adverse effects to the protocol.

It is estimated that this study will take 6 months to complete, and therefore around the 3
month mark or at 15 subjects (whichever comes first) will be the point at which a preliminary
safety study will be done by the research team.

Inclusion Criteria:

- Any patient undergoing laparoscopic hysterectomy

- Benign indications

- Dr. Jamal Mourad or Dr. Nichole Mahnert will be performing hysterectomy

Exclusion Criteria:

- Non-English speakers

- History of chronic opioid use

- History of epilepsy

- History of claustrophobia

- Have received a prescription or taken opioids within 2 weeks for their scheduled
surgery