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Virtual Reality Experiences for Anxiety and Pain Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04759183
Recruitment Status : Active, not recruiting
First Posted : February 18, 2021
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Ryan Li, MD, OHSU Knight Cancer Institute

Study Description
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Brief Summary:
This trial studies the impact of virtual reality experiences on anxiety before surgery and pain after surgery. The goal of this study is to examine how different virtual reality experiences may help reduce anxiety and improve pain control, which may help reduce the need for medications such as opioids.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Survey Administration Procedure: Virtual Reality Game Procedure: Virtual Reality Meditation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Different Virtual Reality Experiences on Anxiety and Pain
Actual Study Start Date : March 5, 2021
Actual Primary Completion Date : April 11, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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.
 Other: Survey Administration
Ancillary studies

Procedure: Virtual Reality Game
Participate in VR Game "Angry Birds"
Other Name: VR Game

Procedure: Virtual Reality Meditation
Participate in VR Meditation "TRIPP"
Other Name: VR Meditation
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.
 Other: Survey Administration
Ancillary studies

Procedure: Virtual Reality Game
Participate in VR Game "Angry Birds"
Other Name: VR Game

Procedure: Virtual Reality Meditation
Participate in VR Meditation "TRIPP"
Other Name: VR Meditation


Outcome Measures
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Primary Outcome Measures :
  1. Change in preoperative anxiety scores [ Time Frame: Baseline up to pre surgery (estimated 1 day) ]
    Assessed by visual analogue scale (VAS) from 0-100mm.

  2. Change in postoperative pain scores [ Time Frame: Baseline after surgery up to study completion (estimated 1 day) ]
    Assessed by VAS scale from 0-100mm.


Secondary Outcome Measures :
  1. Change in blood pressure [ Time Frame: immediately before intervention, and then immediately after intervention (estimated 1 day) ]
    mmHg

  2. 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.

  3. Change in heart rate [ Time Frame: immediately before intervention, and then immediately after intervention (estimated 1 day) ]
    beats per minute (bpm)

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759183


Locations
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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Oregon Health and Science University
Investigators
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Principal Investigator: Ryan J Li OHSU Knight Cancer Institute
More Information
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Responsible Party: Ryan Li, MD, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT04759183    
Other Study ID Numbers: STUDY00022194
NCI-2021-00794 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00022194 ( Other Identifier: OHSU Knight Cancer Institute )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms