Digital Intervention Postoperative Protocol

NCT ID: NCT04828109

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2022-09-01

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.

Conditions

Surgery; Otolaryngologic Disorder; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Virtual Reality

Intervention Type: DEVICE

Use of any virtual reality experiences available

Fitbit

Intervention Type: DEVICE

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

VR Only

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

Group Type: ACTIVE_COMPARATOR

Virtual Reality

Intervention Type: DEVICE

Use of any virtual reality experiences available

Fitbit Only

Fitbit daily step goal of 2,000 steps.

Group Type: ACTIVE_COMPARATOR

Fitbit

Intervention Type: DEVICE

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

Control

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

Use of any virtual reality experiences available

Intervention Type: DEVICE

Fitbit

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Li, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Li, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

00021902

Identifier Type: -

Identifier Source: org_study_id