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

NCT04814524 | Completed

• 2 other identifiers: STUDY00021902NCI-2020-11592
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies examines the impact of virtual reality (VR) experiences and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. Virtual reality has shown to help rehabilitation and pain control primarily in non-surgical fields, and researchers are interested in using this to help postoperative pain control. Early mobilization after surgery is also important, and may increase lung capacity, improve gastrointestinal function, reduce pain, and reduce risk of deep venous thrombosis. Use of virtual reality and Fitbit devices may improve postoperative pain control and reduce narcotic use among hospitalized patients after head and neck surgery.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• Mean daily opioid use

  Will be assessed using milligram morphine equivalents (MME). Narcotic use may be compared using One-Way Analysis of Variance (ANOVA) and two sample t-test can be used to compare the narcotic use between intervention group and control group (virtual reality \[VR\]+Fitbit versus \[vs.\] control, VR vs. control, Fitbit vs. control). Furthermore, a linear regression model including demographic and clinical characteristic variables with a P-value =\< 0.1 will be used to determine factors associated with reduced narcotic use.

  Through study completion, an average of 10 days

Other Outcomes (8)

• Pain scores

  Through study completion (pre and post-VR use), 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

Study Arms (4)

Group 1 (VR, Fitbit)

EXPERIMENTAL

Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends, and wear Fitbit daily with a goal of 2,000 steps until the day of discharge, or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use. Sleep data may also be evaluated from Fitbit devices.

Device: Fitbit; Other: Questionnaire Administration; Device: Virtual Reality Device

Group 2 (VR)

EXPERIMENTAL

Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use.

Other: Questionnaire Administration; Device: Virtual Reality Device

Group 3 (Fitbit)

EXPERIMENTAL

Beginning postoperative day 1, patients wear Fitbit daily with a goal of 2,000 steps until the day of discharge or until 14 days after surgery. Sleep data may also be evaluated from Fitbit devices.

Device: Fitbit; Other: Questionnaire Administration

Group 4 (questionnaire)

ACTIVE COMPARATOR

Patients do not use VR or wear Fitbit.

Other: Questionnaire Administration

Interventions

Fitbit DEVICE

Wear Fitbit

Group 1 (VR, Fitbit); Group 3 (Fitbit)

Questionnaire Administration OTHER

Ancillary studies

Group 1 (VR, Fitbit); Group 2 (VR); Group 3 (Fitbit); Group 4 (questionnaire)

Virtual Reality Device DEVICE

Use VR

Group 1 (VR, Fitbit); Group 2 (VR)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking (Ability to interact with virtual reality content may be impacted by inability to understand English)
• Older than 18 years of age and younger than 89 years of age. Both men and women and members of all races and ethnic groups will be included
• Planned to undergo major surgery at Oregon Health \& Science University (OHSU) with the Department of Otolaryngology-Head and Neck Surgery with an expected length of stay (LOS) of 2 days or more
• Ability to understand and the 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
• Complex head and neck procedure requiring resection or reconstruction involving the scalp, orbit, or mid-face. This would limit the ability to utilize the VR headset
• 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. This would limit the ability to utilize the VR headset or the Fitbit device
• History of seizure or epilepsy
• History of vertigo or persistent dizziness
• Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators
• Limitations that impair mobility. This would limit the ability to utilize the Fitbit device
• Use of a walker or wheelchair at baseline. This would limit the ability to utilize the Fitbit device
• Children
• Pregnant women
• Neonates of uncertain viability or nonviable neonates
• Decisionally impaired adults
• Prisoners

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Study Officials

• Ryan J Li

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: July 1, 2021
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

US (1)