Digital Intervention Postoperative Protocol

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Surgery; Pain, Postoperative; Otolaryngologic Disorder

Treatments: Device: Fitbit; Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT04828109

00021902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

VR and Fitbit

Active Comparator group

Description:

Daily VR use every 3 hours up to 30 minutes at a time and Fitbit daily step goal of 2,000 steps

Treatment:

Device: Fitbit

Device: Virtual Reality

VR Only

Active Comparator group

Description:

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

Treatment:

Device: Virtual Reality

Fitbit Only

Active Comparator group

Description:

Fitbit daily step goal of 2,000 steps.

Treatment:

Device: Fitbit

Control

No Intervention group

Description:

Standard of care