Virtual Reality for Postoperative Pain After Laparoscopic Hysterectomy
Virtual Reality for Postoperative Pain After Laparoscopic Hysterectomy
Patients will be randomized to either receive virtual reality headsets in the post anesthesia
 recovery unit (PACU) as an adjunct therapy or undergo routine postoperative management. Pain
 scores will be recorded at standardized intervals in the PACU. The patient will be asked to
 complete a survey at their two week post op visit assessing their satisfaction with their
 post op recovery.

 The purpose of this study is to determine whether a virtual reality relaxation program used
 in the immediate postoperative period after laparoscopic hysterectomy will decrease pain
 scores and reduce both oral and intravenous opioid consumption.
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