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Postoperative recovery after head and neck surgery is complex, and often requires utilization of narcotic medications. The aim of this study is to evaluate reduction in pain and use of opioid medications through Virtual Reality (VR) and Fitbit wearable activity devices.
Enhanced Recovery After Surgery (ERAS) protocols were introduced as a method to optimize perioperative patient care. Narcotic medications are frequently utilized in postoperative care, but these have risks including sedation or dependence. Non-pharmacologic measures for postoperative pain control may help limit the need for opioids in postoperative pain control.
Early mobilization is also important after surgery, however postoperative mobility is rarely monitored and relies on subjective reports.
The investigators will seek to examine the implementation of an ERAS protocol using VR and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. This is a prospective, 4-arm, randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR and Fitbit | Active Comparator | Daily VR use every 3 hours up to 30 minutes at a time and Fitbit daily step goal of 2,000 steps |
|
| VR Only | Active Comparator | Daily VR only. Daily VR use every 3 hours up to 30 minutes at a time. |
|
| Fitbit Only | Active Comparator | Fitbit daily step goal of 2,000 steps. |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | Use of any virtual reality experiences available |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily opioid use | Mean daily opioid use will be assessed converted into milligram morphine equivalents (MME). | through study completion, an average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | The Numeric Rating Scale (NRS) from 0 to 10 will be used to determine pain scores collected in the morning and evening each day. Scores will be averaged to obtain the daily pain score. We will also look at differences between AM and PM pain scores among the different cohorts. Scores will range from 0 (no pain) to 10 (worst pain) | through study completion, an average of 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Li, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Fitbit | Device | Use of a Fitbit wearable activity device to track daily step goals. |
|
| Anxiety | The Generalized Anxiety Disorder 7-Item scale (GAD-7) will be used to determine preoperative and postoperative level of anxiety. Cut points of 5, 10, and 15 may represent mild, moderate, and severe levels of anxiety. | Before surgery and at study completion, an average of 10 days |
| Depression | The Patient Health Questionaire-9 (PHQ-9) will be used to determine preoperative and postoperative level of depression. PHQ-9 scores can represent mild (<4), moderate (5-14), and severe (>20) depression. | Before surgery and at study completion, an average of 10 days |
| Sleep Quality | The Insomnia Severity Index (ISI) will be used to determine preoperative and postoperative sleep quality. The ISI is a 7-item questionnaire evaluating severity of difficulty with sleep onset, sleep maintenance, early morning awakening, sleep dissatisfaction, interference in daytime functioning, noticeability of sleep difficulties by others, and distress from sleep difficulty. Items are rated on a 5-point Likert scale, and a total score ranges from 0 to 28. | Before surgery and at study completion, an average of 10 days |
| Patient experience and satisfaction | A Visual Analogue Scale (VAS) will used to analyze patient satisfaction during hospitalization, and will be provided to patients on day of discharge. The 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). | at study completion, an average of 10 days |
| Disposition on discharge | Data regarding disposition on discharge to home, home with home health, skilled nursing facility, inpatient rehabilitation facility, or other facility will be determined from the electronic medical record on the day of discharge. | at study completion, an average of 10 days |
| Length of hospital stay | Length of stay will be calculated beginning from postoperative day one and will include the day of discharge. | at study completion, an average of 10 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |