Digital Intervention Postoperative Protocol

NCT04828109 | Completed DMC

• 1 other identifier: 00021902
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Otolaryngologic Disorder; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain scores

  through study completion, an average of 10 days

• Anxiety

  Before surgery and at study completion, an average of 10 days

• Depression

  Before surgery and at study completion, an average of 10 days

• Sleep Quality

  Before surgery and at study completion, an average of 10 days

• Patient experience and satisfaction

  at study completion, an average of 10 days

Study Arms (4)

VR and Fitbit

ACTIVE COMPARATOR

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; Device: Fitbit

VR Only

ACTIVE COMPARATOR

Daily VR only. Daily VR use every 3 hours up to 30 minutes at a time.

Device: Virtual Reality

Fitbit Only

ACTIVE COMPARATOR

Fitbit daily step goal of 2,000 steps.

Device: Fitbit

Control

NO INTERVENTION

Standard of care

Interventions

Virtual Reality DEVICE

Use of any virtual reality experiences available

VR Only; VR and Fitbit

Fitbit DEVICE

Use of a Fitbit wearable activity device to track daily step goals.

Fitbit Only; VR and Fitbit

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ryan Li, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: October 25, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)