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

Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814524
• Other study ID #: STUDY00021902
• Secondary ID: NCI-2020-11592ST
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 6, 2022

Study information

• Verified date: October 2022
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma

Intervention

Device:
• Fitbit
Wear Fitbit

Other:
• Questionnaire Administration
Ancillary studies

Device:
• Virtual Reality Device
Use VR

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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