Digital Intervention Postoperative Protocol

Surgery 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: NCT04828109
• Other study ID #: 00021902
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Otolaryngologic Disorder
• Pain, Postoperative
• Surgery

Intervention

Device:
• Virtual Reality
Use of any virtual reality experiences available
• Fitbit
Use of a Fitbit wearable activity device to track daily step goals.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

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