Clinical trial NCT04828109: Digital Intervention Postoperative Protocol
Official title: A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Otolaryngologic Disorder
Pain, Postoperative
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 80
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: Postoperative recovery after head and neck surgery is complex, and often requires utilization of narcotic medications. The aim of this study is to evaluate reduction in pain and use of opioid medications through Virtual Reality (VR) and Fitbit wearable activity devices.

Detailed description: Enhanced Recovery After Surgery (ERAS) protocols were introduced as a method to optimize perioperative patient care. Narcotic medications are frequently utilized in postoperative care, but these have risks including sedation or dependence. Non-pharmacologic measures for postoperative pain control may help limit the need for opioids in postoperative pain control.

Early mobilization is also important after surgery, however postoperative mobility is rarely monitored and relies on subjective reports.

The investigators will seek to examine the implementation of an ERAS protocol using VR and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. This is a prospective, 4-arm, randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* English speaking
* 18 to 89 years of age.
* Planned to undergo major head and neck surgery OHSU with an expected length of stay of two days or more.
* Ability to understand goals of the study and willingness to sign a written informed consent document.

Exclusion Criteria:

* Planned postoperative admission to the intensive care unit (ICU).
* Social or psychiatric conditions that may interfere with compliance.
* Isolation precautions.
* Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset or wear a Fitbit device around the wrist.
* History of seizure or epilepsy.
* History of vertigo or persistent dizziness.
* Limitations that impair mobility.
* Use of a walker or wheelchair at baseline.

Primary outcomes:
measure: Mean daily opioid use
timeFrame: through study completion, an average of 10 days
Secondary outcomes:
measure: Pain scores
timeFrame: through study completion, an average of 10 days
measure: Anxiety
timeFrame: Before surgery and at study completion, an average of 10 days
measure: Depression
timeFrame: Before surgery and at study completion, an average of 10 days
measure: Sleep Quality
timeFrame: Before surgery and at study completion, an average of 10 days
measure: Patient experience and satisfaction
timeFrame: at study completion, an average of 10 days
measure: Disposition on discharge
timeFrame: at study completion, an average of 10 days
measure: Length of hospital stay
timeFrame: at study completion, an average of 10 days
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: