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

NCT ID: NCT04814524

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-10-06

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 rehabilitation and pain control primarily in non-surgical fields, and researchers are interested in using this to help postoperative pain control. Early mobilization after surgery is also important, and may increase lung capacity, improve gastrointestinal function, reduce pain, and reduce risk of deep venous thrombosis. Use of virtual reality and Fitbit devices may improve postoperative pain control and reduce narcotic use among hospitalized patients after head and neck surgery.

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 daily ambulation goals using Fitbit devices during hospitalization, compared to patients without daily ambulation goals.

III. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization.

EXPLORATORY OBJECTIVES:

I. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization on reducing pain scores, anxiety, depression, and length of stay, and improving sleep quality, hospital satisfaction, and disposition on discharge.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP 1: Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends, and wear Fitbit daily with a goal of 2,000 steps until the day of discharge, or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use. Sleep data may also be evaluated from Fitbit devices.

GROUP 2: Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use.

GROUP 3: Beginning postoperative day 1, patients wear Fitbit daily with a goal of 2,000 steps until the day of discharge or until 14 days after surgery. Sleep data may also be evaluated from Fitbit devices.

GROUP 4: Patients do not use VR or wear Fitbit.

Conditions

Head and Neck Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group 1 (VR, Fitbit)

Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends, and wear Fitbit daily with a goal of 2,000 steps until the day of discharge, or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use. Sleep data may also be evaluated from Fitbit devices.

Group Type: EXPERIMENTAL

Fitbit

Intervention Type: DEVICE

Wear Fitbit

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Virtual Reality Device

Intervention Type: DEVICE

Use VR

Group 2 (VR)

Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use.

Group Type: EXPERIMENTAL

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Virtual Reality Device

Intervention Type: DEVICE

Use VR

Group 3 (Fitbit)

Beginning postoperative day 1, patients wear Fitbit daily with a goal of 2,000 steps until the day of discharge or until 14 days after surgery. Sleep data may also be evaluated from Fitbit devices.

Group Type: EXPERIMENTAL

Fitbit

Intervention Type: DEVICE

Wear Fitbit

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Group 4 (questionnaire)

Patients do not use VR or wear Fitbit.

Group Type: ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Fitbit

Wear Fitbit

Intervention Type: DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Virtual Reality Device

Use VR

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ryan Li, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan J Li

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

NCI-2020-11592

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00021902

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00021902

Identifier Type: -

Identifier Source: org_study_id