Clinical trial NCT04464304: Virtual Reality for Postoperative Pain Management
Official title: Virtual Reality for Postoperative Pain Management After Head and Neck Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Pain, Postoperative
Incision
Otolaryngological Disease
Keywords: Virtual Reality
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies an active virtual reality (VR) experience as a means for non-pharmacologic postoperative pain management among patients after head and neck surgery. Investigators will assess differences in pain scores, analgesic use, and subjective patient experiences between patients participating in a VR activity and patients participating in the same activity using a smartphone.

Detailed description: Management of postoperative pain after head and neck surgery is complex, and has received increased attention to improve patient recovery and quality of life. Narcotic analgesics are frequently utilized in postoperative pain management, but these have risks including nausea, sedation, constipation, and dependence. Multimodal analgesia can reduce narcotic use and improve recovery, but medical comorbidities may contraindicate the use of certain medications. Non-pharmacologic measures for postoperative pain control may provide novel and cost-effective strategies to confront this complex issue.

Patients undergoing head and neck surgery will be randomly allocated to participate in an immersive experience in VR, or to participate in a similar experience on a two-dimensional screen using a smartphone.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone head and neck surgery with an average pain score of 3 or greater out of 10 during the 24 hours preceding the screening
* Are able to provide informed consent
* Are not in the intensive care unit (ICU)

Exclusion Criteria:

* Symptoms concerning for an active respiratory infection including fever, cough, and shortness of breath or confirmed respiratory infection
* Active eye discharge
* Active nausea or vomiting
* History of seizure, epilepsy, or hypersensitivity to flashing light
* History of motion sickness or vertigo
* Have wound dressings on the head or neck that prevent comfortable and safe use of the virtual reality headset

Primary outcomes:
measure: Change in patient-reported pain scores
timeFrame: Up to 4 hours after intervention use
Secondary outcomes:
measure: Opioid usage
timeFrame: Average 24 hours after intervention use
measure: Patient experience
timeFrame: Up to 4 hours after intervention use
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ryan Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pandrangi VC, Shah SN, Bruening JD, Wax MK, Clayburgh D, Andersen PE, Li RJ. Effect of Virtual Reality on Pain Management and Opioid Use Among Hospitalized Patients After Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Aug 1;148(8):724-730. doi: 10.1001/jamaoto.2022.1121.