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Digital Intervention Postoperative Protocol

Primary Purpose

Surgery, Otolaryngologic Disorder, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Fitbit
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgery

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oregon Health and Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

VR and Fitbit

VR Only

Fitbit Only

Control

Arm Description

Daily VR use every 3 hours up to 30 minutes at a time and Fitbit daily step goal of 2,000 steps

Daily VR only. Daily VR use every 3 hours up to 30 minutes at a time.

Fitbit daily step goal of 2,000 steps.

Standard of care

Outcomes

Primary Outcome Measures

Mean daily opioid use
Mean daily opioid use will be assessed converted into milligram morphine equivalents (MME).

Secondary Outcome Measures

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)
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.
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.
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.
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).
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.
Length of hospital stay
Length of stay will be calculated beginning from postoperative day one and will include the day of discharge.

Full Information

First Posted
March 28, 2021
Last Updated
October 25, 2021
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT04828109
Brief Title
Digital Intervention Postoperative Protocol
Official Title
A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Otolaryngologic Disorder, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR and Fitbit
Arm Type
Active Comparator
Arm Description
Daily VR use every 3 hours up to 30 minutes at a time and Fitbit daily step goal of 2,000 steps
Arm Title
VR Only
Arm Type
Active Comparator
Arm Description
Daily VR only. Daily VR use every 3 hours up to 30 minutes at a time.
Arm Title
Fitbit Only
Arm Type
Active Comparator
Arm Description
Fitbit daily step goal of 2,000 steps.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
Use of any virtual reality experiences available
Intervention Type
Device
Intervention Name(s)
Fitbit
Intervention Description
Use of a Fitbit wearable activity device to track daily step goals.
Primary Outcome Measure Information:
Title
Mean daily opioid use
Description
Mean daily opioid use will be assessed converted into milligram morphine equivalents (MME).
Time Frame
through study completion, an average of 10 days
Secondary Outcome Measure Information:
Title
Pain scores
Description
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)
Time Frame
through study completion, an average of 10 days
Title
Anxiety
Description
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.
Time Frame
Before surgery and at study completion, an average of 10 days
Title
Depression
Description
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.
Time Frame
Before surgery and at study completion, an average of 10 days
Title
Sleep Quality
Description
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.
Time Frame
Before surgery and at study completion, an average of 10 days
Title
Patient experience and satisfaction
Description
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).
Time Frame
at study completion, an average of 10 days
Title
Disposition on discharge
Description
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.
Time Frame
at study completion, an average of 10 days
Title
Length of hospital stay
Description
Length of stay will be calculated beginning from postoperative day one and will include the day of discharge.
Time Frame
at study completion, an average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivek Pandrangi, MD
Phone
5044945355
Email
pandrang@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Li, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivek Pandrangi, MD
Phone
503-494-5355
First Name & Middle Initial & Last Name & Degree
Ryan Li, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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