A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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Evaluate the effectiveness of daily virtual reality (VR) utilization during hospitalization in reducing narcotic use, compared to patients not utilizing VR.
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Evaluate the effectiveness of daily ambulation goals using Fitbit devices during hospitalization in reducing narcotic use, compared to patients without daily ambulation goals.
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Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization in reducing narcotic use compared to patients utilizing only VR, only Fitbit ambulation goals, and a control group using no digital interventions.
EXPLORATORY OBJECTIVES:
- 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 daily over 30 minutes every 3 hours, 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 after each VR use. Sleep data will also be evaluated from Fitibt devices.
GROUP 2: Beginning postoperative day 1, patients use VR daily over 30 minutes every 3 hours until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained after 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 will also be evaluated from Fitibt devices.
GROUP 4: Patients do not use VR or wear Fitbit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 (VR, Fitbit) Beginning postoperative day 1, patients use VR daily over 30 minutes every 3 hours, 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 after each VR use. Sleep data will also be evaluated from Fitibt devices. |
Device: Fitbit
Wear Fitbit
Other: Questionnaire Administration
Ancillary studies
Device: Virtual Reality Device
Use VR
|
| Experimental: Group 2 (VR) Beginning postoperative day 1, patients use VR daily over 30 minutes every 3 hours until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained after 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 will also be evaluated from Fitibt devices. |
Device: Fitbit
Wear Fitbit
Other: Questionnaire Administration
Ancillary studies
|
| Active Comparator: Group 4 (questionnaire) Patients do not use VR or wear Fitbit. |
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Mean daily opioid use [Through study completion, an average of 10 days]
Will be assessed using milligram morphine equivalents (MME). Two-sample t-test will 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.
Other Outcome Measures
- Pain scores [Through study completion (pre and post-VR use), an average of 10 days]
The Numeric Rating Scale from 0 to 10 will be used to determine pain scores collected in the morning and evening each day. The NRS is an 11-point scale that requires patients to rate pain on a scale from 0 to 10, 0 indicating no pain and 10 indicating the most severe pain. Scores may represent no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10). Scores will be averaged to obtain the daily pain score. Will also look at differences between AM and PM pain scores among the different cohorts. Descriptive statistics will be used to present the results of pain scores. One-way ANOVA and two-sample t-test will be used to compare differences between the groups.
- Anxiety [Before surgery and at study completion, an average of 10 days]
The Generalized Anxiety Disorder 7-Item scale will be used to determine preoperative and postoperative level of anxiety. Scores may represent mild (6-10), moderate (11-15), and severe (16-21) anxiety. Descriptive statistics will be used to present the results of anxiety. One-way ANOVA and two-sample t-test will be used to compare differences between the groups.
- Depression [Before surgery and at study completion, an average of 10 days]
The Patient Health Questionaire-9 will be used 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 will be used to present the results of depression. One-way ANOVA and two-sample t-test will be used to compare differences between the groups.
- Sleep quality [Before surgery and at study completion, an average of 10 days]
The Insomnia Severity Index will be used 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 will be used to present the results of sleep quality. One-way ANOVA and two-sample t-test will be used to compare differences between the groups.
- Hospital satisfaction [At study completion, an average of 10 days]
A Visual Analogue Scale will used to analyze patient satisfaction during hospitalization, and will 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 will be used to present the results of hospital satisfaction. One-way ANOVA and two-sample t-test will be used to compare differences between the groups.
- Disposition on discharge [At study completion, an average of 10 days]
Data regarding disposition on discharge to home, home with home health, skilled nursing facility, inpatient rehabilitation facility, remain in hospital, or other facility will be determined from the electronic medical record on the day of discharge. Descriptive statistics will be used to present the results of disposition on discharge. Chi-square test will be used to compare differences between the groups.
- Length of stay (LOS) [At study completion, an average of 10 days]
LOS will be determined calculated beginning from postoperative day one and will include the day of discharge. Descriptive statistics will be used to present the results of LOS. One-way ANOVA and two-sample t-test will be used to analyze differences between the groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
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English speaking (Ability to interact with virtual reality content may be impacted by inability to understand English)
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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
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Planned to undergo major head and neck surgery Oregon Health & Science University (OHSU) with an expected length of stay of two days or more
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Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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Planned postoperative admission to the intensive care unit (ICU)
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Social or psychiatric conditions that may interfere with compliance
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Isolation precautions
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Active eye discharge
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Complex head and neck procedure requiring resection reconstruction, or wound care involving the scalp, orbit, or mid-face. This would limit the ability to utilize the VR headset
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History of seizure or epilepsy
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History of vertigo or persistent dizziness
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History of hypersensitivity to flashing lights
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Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators
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Limitations that impair mobility. This would limit the ability to utilize the Fitbit device
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Use of a walker or wheelchair at baseline. This would limit the ability to utilize the Fitbit device
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Children
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Pregnant women
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Neonates of uncertain viability or nonviable neonates
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Decisionally impaired adults
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Prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OHSU Knight Cancer Institute | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- OHSU Knight Cancer Institute
- Oregon Health and Science University
Investigators
- Principal Investigator: Ryan J Li, OHSU Knight Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00021902
- NCI-2020-11592
- STUDY00021902