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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Device: Fitbit; Device: Virtual Reality Device

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (VR, 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.	Other: Questionnaire Administration; Ancillary studies; Device: Fitbit; Wear Fitbit; Device: Virtual Reality Device; Use VR
Experimental: Group 2 (VR); 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; Ancillary studies; Device: Virtual Reality Device; Use VR
Experimental: Group 3 (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.	Other: Questionnaire Administration; Ancillary studies; Device: Fitbit; Wear Fitbit
Active Comparator: Group 4 (questionnaire); Patients do not use VR or wear Fitbit.	Other: Questionnaire Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Will review the electronic medical record (EMR) to evaluate daily pain scores among patients, and average these scores to obtain the daily pain score. May also look at differences between AM and PM pain scores among the different cohorts. Additionally, we plan to evaluate pain scores obtained pre and post-VR use. Descriptive statistics can be used to present the results of anxiety. One-way ANOVA and two-sample t-test can be used to compare differences between the groups.	Through study completion (pre and post-VR use), an average of 10 days
Anxiety	Will use the Generalized Anxiety Disorder 7-Item scale to determine preoperative and postoperative level of anxiety. Scores may represent mild (6-10), moderate (11-15), and severe (16-21) anxiety. Descriptive statistics can be used to present the results of anxiety. One-way ANOVA and two-sample t-test can be used to compare differences between the groups.	Before surgery and at study completion, an average of 10 days
Depression	Will use the Patient Health Questionaire-9 to determine preoperative and postoperative level of depression. This is a screening instrument with 9 items that measures depression, with answers as not at all, several days, more than half of the days, and nearly every day (score 0-27). Scores may represent mild (5-9), moderate (10-19), and severe (>= 20) depression. Descriptive statistics can be used to present the results of depression. One-way ANOVA and two-sample t-test can be used to compare differences between the groups.	Before surgery and at study completion, an average of 10 days
Sleep quality	Will use the Insomnia Severity Index to determine preoperative and postoperative sleep quality. Items are rated on a 5-point Likert scale, and a total score ranges from 0 to 28. Scores may represent subthreshold (8-14), moderate (15-21), or severe (22-28) insomnia. Descriptive statistics can be used to present the results of sleep quality. One-way ANOVA and two-sample t-test can be used to compare differences between the groups.	Before surgery and at study completion, an average of 10 days
Sleep patterns	Will evaluate sleep patterns among patients with Fitbit devices to better understand inpatient sleep in the hospital. Descriptive statistics can be used to present the results of LOS. One-way and two-sample t-test can be used to analyze differences between the groups.	At study completion, an average of 10 days
Hospital satisfaction	Will use a Visual Analogue Scale to analyze patient satisfaction during hospitalization, and which would be provided to patients on day of discharge. The Visual Analogue Scale (VAS) is a horizontal line that is 100-mm long, with no satisfaction (0) on the very left and extreme satisfaction on the very right (100). Descriptive statistics can be used to present the results of hospital satisfaction. One-way ANOVA and two-sample t-test can be used to compare differences between the groups.	At study completion, an average of 10 days
Disposition on discharge	Will evaluate data regarding disposition on discharge to home, home with home health, skilled nursing facility, inpatient rehabilitation facility, remain in hospital, other facility, or remaining in the hospital from the EMR on the day of discharge or day 14 of hospital stay. Descriptive statistics can be used to present the results of disposition on discharge. Chi-square test can be used to compare differences between the groups.	At study completion, an average of 10 days
Length of stay (LOS)	Will determine LOS beginning from postoperative day one and to include the day of discharge. Descriptive statistics can be used to present the results of LOS. One-way ANOVA and two-sample t-test can be used to analyze differences between the groups.	At study completion, an average of 10 days

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Ryan J Li, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00021902 (Other Identifier: OHSU Knight Cancer Institute); NCI-2020-11592 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No