- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04828980
Utilization of Different Virtual Reality Experiences
Impact of Different Virtual Reality Experiences on Anxiety and Pain
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mindfulness Virtual Reality Experience
Patients will be provided with a mindfulness VR experience for use up to 15 minutes at bedside.
|
This is a VR experience that focuses on meditation and mindfulness
|
Active Comparator: Gaming Virtual Reality Experience
Patients will be provided with an active gaming VR experience for use up to 15 minutes at bedside.
|
This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient-reported anxiety
Time Frame: baseline, and then 15 minutes later after VR use
|
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)
|
baseline, and then 15 minutes later after VR use
|
Change in patient-reported pain
Time Frame: baseline, and then 15 minutes later after VR use
|
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)
|
baseline, and then 15 minutes later after VR use
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure
Time Frame: baseline, and then 15 minutes later after VR use
|
Blood pressure (mmHG) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.
|
baseline, and then 15 minutes later after VR use
|
Patient experience
Time Frame: 1 minute after use of VR
|
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)
|
1 minute after use of VR
|
Change in heart rate
Time Frame: baseline, and then 15 minutes later after VR use
|
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.
|
baseline, and then 15 minutes later after VR use
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ryan Li, MD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00022194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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