Digital Intervention Postoperative Protocol

A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Surgery; Otolaryngologic Disorder
• Intervention / Treatment: Device: Virtual Reality; Device: Fitbit

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Active Comparator: VR and Fitbit; Daily VR use every 3 hours up to 30 minutes at a time and Fitbit daily step goal of 2,000 steps	Device: Virtual Reality; Use of any virtual reality experiences available; Device: Fitbit; Use of a Fitbit wearable activity device to track daily step goals.
Active Comparator: VR Only; Daily VR only. Daily VR use every 3 hours up to 30 minutes at a time.	Device: Virtual Reality; Use of any virtual reality experiences available
Active Comparator: Fitbit Only; Fitbit daily step goal of 2,000 steps.	Device: Fitbit; Use of a Fitbit wearable activity device to track daily step goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean daily opioid use	Mean daily opioid use will be assessed converted into milligram morphine equivalents (MME).	through study completion, an average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	The Numeric Rating Scale (NRS) from 0 to 10 will be used to determine pain scores collected in the morning and evening each day. Scores will be averaged to obtain the daily pain score. We will also look at differences between AM and PM pain scores among the different cohorts. Scores will range from 0 (no pain) to 10 (worst pain)	through study completion, an average of 10 days
Anxiety	The Generalized Anxiety Disorder 7-Item scale (GAD-7) will be used to determine preoperative and postoperative level of anxiety. Cut points of 5, 10, and 15 may represent mild, moderate, and severe levels of anxiety.	Before surgery and at study completion, an average of 10 days
Depression	The Patient Health Questionaire-9 (PHQ-9) will be used to determine preoperative and postoperative level of depression. PHQ-9 scores can represent mild (<4), moderate (5-14), and severe (>20) depression.	Before surgery and at study completion, an average of 10 days
Sleep Quality	The Insomnia Severity Index (ISI) will be used to determine preoperative and postoperative sleep quality. The ISI is a 7-item questionnaire evaluating severity of difficulty with sleep onset, sleep maintenance, early morning awakening, sleep dissatisfaction, interference in daytime functioning, noticeability of sleep difficulties by others, and distress from sleep difficulty. Items are rated on a 5-point Likert scale, and a total score ranges from 0 to 28.	Before surgery and at study completion, an average of 10 days
Patient experience and satisfaction	A Visual Analogue Scale (VAS) will used to analyze patient satisfaction during hospitalization, and will be provided to patients on day of discharge. The VAS is a horizontal line that is 100-mm long, with no satisfaction (0) on the very left and extreme satisfaction on the very right (100).	at study completion, an average of 10 days
Disposition on discharge	Data regarding disposition on discharge to home, home with home health, skilled nursing facility, inpatient rehabilitation facility, or other facility will be determined from the electronic medical record on the day of discharge.	at study completion, an average of 10 days
Length of hospital stay	Length of stay will be calculated beginning from postoperative day one and will include the day of discharge.	at study completion, an average of 10 days

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Ryan Li, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 00021902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No