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

Not Applicable

Completed

• Conditions: Head and Neck Carcinoma
• Interventions: Device: Fitbit; Device: Virtual Reality Device; Other: Questionnaire Administration

• Registration Number: NCT04814524
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the effectiveness of daily virtual reality (VR) therapy during hospitalization, compared to patients not utilizing daily VR therapy.

II. Evaluate the effectiveness of daily ambulation goals using Fitbit devices during hospitalization, compared to patients without daily ambulation goals.

III. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization.

EXPLORATORY OBJECTIVES:

I. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization on reducing pain scores, anxiety, depression, and length of stay, and improving sleep quality, hospital satisfaction, and disposition on discharge.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP 1: 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.

GROUP 2: 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.

GROUP 3: 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.

GROUP 4: Patients do not use VR or wear Fitbit.

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-07-01
• Status Verified: 2022-10
• Primary Completion: 2022-10-06
• Study Completion: 2022-10-06
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (VR)	Virtual Reality Device	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.
Group 3 (Fitbit)	Questionnaire Administration	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.
Group 1 (VR, Fitbit)	Questionnaire Administration	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.
Group 1 (VR, Fitbit)	Fitbit	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.
Group 1 (VR, Fitbit)	Virtual Reality Device	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.
Group 2 (VR)	Questionnaire Administration	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.
Group 3 (Fitbit)	Fitbit	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.
Group 4 (questionnaire)	Questionnaire Administration	Patients do not use VR or wear Fitbit.

Primary Outcome Measures

Name	Time	Method
Mean daily opioid use	Through study completion, an average of 10 days	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.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States