SurgeryNCT04828109
Digital Intervention Postoperative Protocol
A study testing Virtual Reality and Fitbit in people with Surgery and Otolaryngologic Disorder, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Otolaryngologic Disorder, Pain, Postoperative
- What is being tested?
- Virtual Reality and Fitbit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
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.
Read the 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.
- Conditions
- Surgery, Otolaryngologic Disorder, Pain, Postoperative
- Being tested
- Virtual Reality, Fitbit
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Use of any virtual reality experiences available
FitbitDevice
Use of a Fitbit wearable activity device to track daily step goals.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Virtual Reality; Device: Fitbit |
| VR Only | Active comparator | Daily VR only. Daily VR use every 3 hours up to 30 minutes at a time. Receives: Device: Virtual Reality |
| Fitbit Only | Active comparator | Fitbit daily step goal of 2,000 steps. Receives: Device: Fitbit |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily opioid use
Mean daily opioid use will be assessed converted into milligram morphine equivalents (MME).
Measured: through study completion, an average of 10 days
Secondary outcomes (7)
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)
Measured: through study completion, an average of 10 days
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: at study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start25 Oct 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Li, MD, Oregon Health and Science University
- Investigators
- Ryan Li, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828109
- Sponsor's protocol ID
- 00021902
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT04828109
- Acronym / sponsor ID
- 00021902
- Conditions
- Surgery, Otolaryngologic Disorder, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VR and Fitbit | Active comparator | Device: Virtual Reality, Device: FitbitDaily 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 | Device: Virtual RealityDaily VR only. Daily VR use every 3 hours up to 30 minutes at a time. |
| Fitbit Only | Active comparator | Device: FitbitFitbit daily step goal of 2,000 steps. |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityUse of any virtual reality experiences available | Device | VR Only, VR and Fitbit |
| FitbitUse of a Fitbit wearable activity device to track daily step goals. | Device | Fitbit Only, VR and Fitbit |
Primary outcome
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).
7 secondary outcomes
Pain scores
Time frame: through study completion, an average of 10 days
Anxiety
Time frame: Before surgery and at study completion, an average of 10 days
Depression
Time frame: Before surgery and at study completion, an average of 10 days
Sleep Quality
Time frame: Before surgery and at study completion, an average of 10 days
Patient experience and satisfaction
Time frame: at study completion, an average of 10 days
Disposition on discharge
Time frame: at study completion, an average of 10 days
Length of hospital stay
Time frame: at study completion, an average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Li, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Fitbit in people with Surgery and Otolaryngologic Disorder, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily opioid use (time frame: through study completion, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.