NCT04814524

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
DEVICE	Fitbit	Wear Fitbit
OTHER	Questionnaire Administration	Ancillary studies
DEVICE	Virtual Reality Device	Use VR

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-10-06
• Completion: 2022-10-06
• First posted: 2021-03-24
• Last updated: 2022-10-13

Locations

1 site across 1 country: United States