Skip to main content
OpenTrials
Completed

NCT Number: NCT04828109

Digital Intervention Postoperative Protocol

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery Neurologic Manifestations Otolaryngologic Disorder Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality

Device

Use of any virtual reality experiences available

Fitbit

Device

Use of a Fitbit wearable activity device to track daily step goals.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.