Status:
COMPLETED
A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Head and Neck Carcinoma
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
This trial studies examines the impact of virtual reality (VR) experiences and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. Virtual reality has shown to help...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the effectiveness of daily virtual reality (VR) therapy during hospitalization, compared to patients not utilizing daily VR therapy. II. Evaluate the effectiveness of...
Eligibility Criteria
Inclusion
- English speaking (Ability to interact with virtual reality content may be impacted by inability to understand English)
- Older than 18 years of age and younger than 89 years of age. Both men and women and members of all races and ethnic groups will be included
- Planned to undergo major surgery at Oregon Health \& Science University (OHSU) with the Department of Otolaryngology-Head and Neck Surgery with an expected length of stay (LOS) of 2 days or more
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Planned postoperative admission to the intensive care unit (ICU)
- Social or psychiatric conditions that may interfere with compliance
- Isolation precautions
- Complex head and neck procedure requiring resection or reconstruction involving the scalp, orbit, or mid-face. This would limit the ability to utilize the VR headset
- 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. This would limit the ability to utilize the VR headset or the Fitbit device
- History of seizure or epilepsy
- History of vertigo or persistent dizziness
- Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators
- Limitations that impair mobility. This would limit the ability to utilize the Fitbit device
- Use of a walker or wheelchair at baseline. This would limit the ability to utilize the Fitbit device
- Children
- Pregnant women
- Neonates of uncertain viability or nonviable neonates
- Decisionally impaired adults
- Prisoners
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04814524
Start Date
July 1 2021
End Date
October 6 2022
Last Update
October 13 2022
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239