Bariatric Surgery Candidate, Postoperative Complications, Postoperative Pain
Conditions
Keywords
Virtual Reality, ERAS
Brief summary
The objective of this study is to investigate whether the addition of immersive virtual reality (VR) in the immediate postoperative period to an enhanced recovery after surgery (ERAS) protocol could improve postoperative recovery from bariatric surgery.
Detailed description
The investigators propose conducting a randomized, controlled, single-center clinical trial of patients recovering from laparoscopic bariatric surgery. The objective is to investigate whether the use of virtual reality (VR) during the immediate postoperative period could improve patient reported quality of recovery and potentially reduce opioid analgesic requirements as compared to an existing ERAS protocol. The investigators hypothesize that immersive VR will improve subjective quality of recovery scores at time of Post Anesthesia Care Unit (PACU) discharge as compared to standard ERAS.
Interventions
The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.
Sponsors
Beth Israel Deaconess Medical Center
Israel-United States Binational Industrial Research and Development Foundation
XRHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors of the QOR15 recovery scale will be blinded to group assignment.
Intervention model description
Research participants will be randomized to one of two groups: immersive VR plus ERAS, or ERAS alone in a 1:1 allocation. The first 6 patients enrolled will be assigned to the VR group for the purposes of a pilot phase with the objective of identifying and refining any issues with the intervention. Data for these patients will not be included in the statistical analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients undergoing laparoscopic bariatric surgery at BIDMC under general anesthesia.
Exclusion criteria
* Age\<18 * Open wounds or active infection of the face or eye area * History of seizures or other symptom linked to an epileptic condition * Patients with hearing aids who are unable to tolerate wearing headphones with their hearing aids * Patients with a pacemaker or other implanted medical device * Droplet or airborne precautions (as determined by BIDMC infection control policy) * Non English Speaking or non Spanish Speaking * Chronic opioid dependence (existing oral opioid prescription for \>3 months, methadone, suboxone) Drop Out Criteria: (after enrollment and randomization, before intervention) \- Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery Questionnaires (QoR-15) | Measured at time of post anesthesia care unit discharge, on average of 1 to 5 hours after surgery. | The primary outcome of this study will be patient reported quality of recovery at time of PACU discharge, as assessed by the QOR-15. The QOR-15 is a validated instrument to assess postoperative recovery from the patient's perspective, assessing overall well-being, nausea, pain, and anxiety and depression following surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PACU Opioid Requirements | Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery. | The postoperative opioid requirements following the patients surgery, will be measured in milligrams and converted to morphine dose equivalents. |
| Length of PACU stay | Duration of the patient's stay in the post anesthesia care unit, from time of admission to time of readiness for PACU discharge, on average 1 to 5 hours. | The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes. |
| PACU pain scores using numeric rating scale | Administered every hour following admission to the post anesthesia care unit until discharge from the post anesthesia care unit, on average 1 to 5 hours. | Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome). |
| Postoperative Quality of Recovery Questionnaires (QoR-15) score | Measured at 24 hours after post anesthesia unit discharge. | The QOR-15 is a validated instrument to assess postoperative recovery from the patient's perspective, assessing overall well-being, nausea, pain, and anxiety and depression following surgery. |
| Hospital length of stay | Measured throughout the patients stay at the hospital, on average 1 to 3 days. | The length of the patients stay following surgery. |
| Opioid requirements | Measured throughout the patients stay at the hospital, on average 1 to 3 days. | Opioid requirements throughout the hospital stay. |
| Opioid-related adverse effects | Measured throughout the patients stay at the hospital, on average 1 to 3 days. | Opioid-related adverse effects such as nausea or ileus. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian P O'Gara, MD,MP
Beth Israel Deaconess Medical Center
Outcome results
None listed