- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04759183
Virtual Reality Experiences for Anxiety and Pain Control
Impact of Different Virtual Reality Experiences on Anxiety and Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To measure the impact of a gaming virtual reality (VR) experience compared to a mindfulness VR experience on preoperative anxiety and postoperative pain.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in a VR intervention (Angry Birds) over 15 minutes before standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes after surgery.
ARM II: Patients participate in a VR intervention (TRIPP) over 15 minutes before standard of care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
United States
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults (18 years or older and younger than 89)
- Able to consent
- English-speaking
Exclusion Criteria:
- Non-English speaking patients because the VR content is only available in English
- Have symptoms concerning for an active respiratory infection or are on contact or isolation precautions
- Any active eye discharge
- A history of seizure, epilepsy, or hypersensitivity to flashing light
- Have a history of motion sickness or vertigo
- Have active nausea or vomiting
- Psychiatric conditions that may interfere with the ability to successfully participate in the study
- Have cardiac pacemakers
- Require hearing aids at all times that cannot be removed
- Have defibrillators
- Have wound dressings on the head or neck that prevent comfortable 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 |
---|---|
Experimental: Arm I (Angry Birds, TRIPP)
Patients participate in a VR intervention (Angry Birds) over 15 minutes before standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes after surgery.
|
Ancillary studies
Participate in VR Game "Angry Birds"
Other Names:
Participate in VR Meditation "TRIPP"
Other Names:
|
Experimental: Arm II (TRIPP, Angry Birds)
Patients participate in a VR intervention (TRIPP) over 15 minutes before standard of care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after surgery.
|
Ancillary studies
Participate in VR Game "Angry Birds"
Other Names:
Participate in VR Meditation "TRIPP"
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preoperative anxiety scores
Time Frame: Baseline up to pre surgery (estimated 1 day)
|
Assessed by visual analogue scale (VAS) from 0-100mm.
|
Baseline up to pre surgery (estimated 1 day)
|
Change in postoperative pain scores
Time Frame: Baseline after surgery up to study completion (estimated 1 day)
|
Assessed by VAS scale from 0-100mm.
|
Baseline after surgery up to study completion (estimated 1 day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure
Time Frame: immediately before intervention, and then immediately after intervention (estimated 1 day)
|
mmHg
|
immediately before intervention, and then immediately after intervention (estimated 1 day)
|
Patient enjoyment of each VR experience
Time Frame: Up to study completion (estimated 1 day)
|
Likert scale (1-5). 1 represents the lowest score, and 5 represents the highest.
|
Up to study completion (estimated 1 day)
|
Change in heart rate
Time Frame: immediately before intervention, and then immediately after intervention (estimated 1 day)
|
beats per minute (bpm)
|
immediately before intervention, and then immediately after intervention (estimated 1 day)
|
Patient desire to use VR more in their healthcare
Time Frame: Up to study completion (estimated 1 day)
|
Likert scale (1-5). 1 represents the lowest score, and 5 represents the highest.
|
Up to study completion (estimated 1 day)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan J Li, OHSU Knight Cancer Institute
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
- STUDY00022194 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2021-00794 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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