Utilization of Different Virtual Reality Experiences
Primary Purpose
Surgery, Pain, Postoperative, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculus Quest: TRIPP
Oculus Quest: Angry Birds
Sponsored by
About this trial
This is an interventional supportive care trial for Surgery
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing head and neck surgery
- Are able to provide informed consent
Exclusion Criteria:
- Isolation precautions
- Active eye discharge
- Active nausea or vomiting
- History of seizure, epilepsy, or hypersensitivity to flashing light
- Expected to have wounds or wound care that prevent comfortable and safe use of the VR headset
Sites / Locations
- Oregon Health and Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mindfulness Virtual Reality Experience
Gaming Virtual Reality Experience
Arm Description
Patients will be provided with a mindfulness VR experience for use up to 15 minutes at bedside.
Patients will be provided with an active gaming VR experience for use up to 15 minutes at bedside.
Outcomes
Primary Outcome Measures
Change in patient-reported anxiety
Anxiety level will be obtained using a 100mm Visual Analogue Scale (VAS). Preoperative anxiety scores will be obtained prior to VR then immmediately after VR use to assess change in anxiety after each intervention. Score will range from 0 (no anxiety) to 100 (extremely anxious)
Change in patient-reported pain
Pain level will be obtained using a 100mm Visual Analogue Scale (VAS). Postoperative pain scores will be obtained prior to VR then immmediately after VR use to assess change in pain level after each intervention. Score will range from 0 (no pain) to 100 (worst pain imaginable)
Secondary Outcome Measures
Change in blood pressure
Blood pressure (mmHG) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.
Patient experience
Patients will complete a short survey at the completion of their participation in each VR experience evaluating their experience using a 5-point Likert scale, with responses ranging from 1 (low satisfaction) to 5 (high satisfaction)
Change in heart rate
Heart rate (beats per minute [bpm]) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.
Full Information
NCT ID
NCT04828980
First Posted
March 28, 2021
Last Updated
March 30, 2021
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT04828980
Brief Title
Utilization of Different Virtual Reality Experiences
Official Title
Impact of Different Virtual Reality Experiences on Anxiety and Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
May 1, 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
No
5. Study Description
Brief Summary
This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.
Detailed Description
Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications.
This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Pain, Postoperative, Anxiety, Otolaryngological Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Virtual Reality Experience
Arm Type
Active Comparator
Arm Description
Patients will be provided with a mindfulness VR experience for use up to 15 minutes at bedside.
Arm Title
Gaming Virtual Reality Experience
Arm Type
Active Comparator
Arm Description
Patients will be provided with an active gaming VR experience for use up to 15 minutes at bedside.
Intervention Type
Device
Intervention Name(s)
Oculus Quest: TRIPP
Intervention Description
This is a VR experience that focuses on meditation and mindfulness
Intervention Type
Device
Intervention Name(s)
Oculus Quest: Angry Birds
Intervention Description
This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.
Primary Outcome Measure Information:
Title
Change in patient-reported anxiety
Description
Anxiety level will be obtained using a 100mm Visual Analogue Scale (VAS). Preoperative anxiety scores will be obtained prior to VR then immmediately after VR use to assess change in anxiety after each intervention. Score will range from 0 (no anxiety) to 100 (extremely anxious)
Time Frame
baseline, and then 15 minutes later after VR use
Title
Change in patient-reported pain
Description
Pain level will be obtained using a 100mm Visual Analogue Scale (VAS). Postoperative pain scores will be obtained prior to VR then immmediately after VR use to assess change in pain level after each intervention. Score will range from 0 (no pain) to 100 (worst pain imaginable)
Time Frame
baseline, and then 15 minutes later after VR use
Secondary Outcome Measure Information:
Title
Change in blood pressure
Description
Blood pressure (mmHG) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.
Time Frame
baseline, and then 15 minutes later after VR use
Title
Patient experience
Description
Patients will complete a short survey at the completion of their participation in each VR experience evaluating their experience using a 5-point Likert scale, with responses ranging from 1 (low satisfaction) to 5 (high satisfaction)
Time Frame
1 minute after use of VR
Title
Change in heart rate
Description
Heart rate (beats per minute [bpm]) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.
Time Frame
baseline, and then 15 minutes later after VR use
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:
Patients undergoing head and neck surgery
Are able to provide informed consent
Exclusion Criteria:
Isolation precautions
Active eye discharge
Active nausea or vomiting
History of seizure, epilepsy, or hypersensitivity to flashing light
Expected to have wounds or wound care that prevent comfortable and safe use of the VR headset
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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Utilization of Different Virtual Reality Experiences
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