Digital Intervention Postoperative Protocol

• ClinicalTrials.gov Identifier: NCT04828109
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: November 1, 2021
• Sponsor: Oregon Health and Science University
• Information provided by (Responsible Party): Ryan Li, MD, Oregon Health and Science University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Surgery; Otolaryngologic Disorder; Pain, Postoperative	Device: Virtual Reality; Device: Fitbit	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
• Actual Study Start Date: October 25, 2021
• Estimated Primary Completion Date: July 1, 2022
• Estimated Study Completion Date: July 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: VR and Fitbit; Daily VR use every 3 hours up to 30 minutes at a time and Fitbit daily step goal of 2,000 steps	Device: Virtual Reality; Use of any virtual reality experiences available; Device: Fitbit; Use of a Fitbit wearable activity device to track daily step goals.
Active Comparator: VR Only; Daily VR only. Daily VR use every 3 hours up to 30 minutes at a time.	Device: Virtual Reality; Use of any virtual reality experiences available
Active Comparator: Fitbit Only; Fitbit daily step goal of 2,000 steps.	Device: Fitbit; Use of a Fitbit wearable activity device to track daily step goals.
No Intervention: Control; Standard of care

Outcome Measures

Primary Outcome Measures :

1. Mean daily opioid use [ Time Frame: through study completion, an average of 10 days ]
   Mean daily opioid use will be assessed converted into milligram morphine equivalents (MME).

Secondary Outcome Measures :

1. Pain scores [ Time Frame: through study completion, an average of 10 days ]
   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)
2. Anxiety [ Time Frame: Before surgery and at study completion, an average of 10 days ]
   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.
3. Depression [ Time Frame: Before surgery and at study completion, an average of 10 days ]
   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.
4. Sleep Quality [ Time Frame: Before surgery and at study completion, an average of 10 days ]
   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.
5. Patient experience and satisfaction [ Time Frame: at study completion, an average of 10 days ]
   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).
6. Disposition on discharge [ Time Frame: 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, or other facility will be determined from the electronic medical record on the day of discharge.
7. Length of hospital stay [ Time Frame: at study completion, an average of 10 days ]
   Length of stay will be calculated beginning from postoperative day one and will include the day of discharge.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• English speaking
• 18 to 89 years of age.
• Planned to undergo major head and neck surgery OHSU with an expected length of stay of two days or more.
• Ability to understand goals of the study and 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.
• 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.
• History of seizure or epilepsy.
• History of vertigo or persistent dizziness.
• Limitations that impair mobility.
• Use of a walker or wheelchair at baseline.

Contacts and Locations

Contacts

Contact: Vivek Pandrangi, MD; 5044945355; pandrang@ohsu.edu

Locations

United States, Oregon

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: Vivek Pandrangi, MD 503-494-5355

Principal Investigator: Ryan Li, MD

Sponsors and Collaborators

Oregon Health and Science University

Investigators

• Principal Investigator: Ryan Li, MD; Oregon Health and Science University

More Information

• Responsible Party: Ryan Li, MD, Principal Investigator, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT04828109
• Other Study ID Numbers: 00021902
• First Posted: April 1, 2021
• Last Update Posted: November 1, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations