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Clinical Trials/NCT04759183
NCT04759183CompletedNot Applicable

Impact of Different Virtual Reality Experiences on Anxiety and Pain

OHSU Knight Cancer Institute2 sites in 1 country32 target enrollmentStarted: March 5, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
Change in postoperative pain scores

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Change in postoperative pain scores

Time Frame: Baseline after surgery up to study completion (estimated 1 day)

Assessed by VAS scale from 0-100mm.

Change in preoperative anxiety scores

Time Frame: Baseline up to pre surgery (estimated 1 day)

Assessed by visual analogue scale (VAS) from 0-100mm.

Secondary Outcomes

  • Change in blood pressure(immediately before intervention, and then immediately after intervention (estimated 1 day))
  • Patient enjoyment of each VR experience(Up to study completion (estimated 1 day))
  • Change in heart rate(immediately before intervention, and then immediately after intervention (estimated 1 day))
  • Patient desire to use VR more in their healthcare(Up to study completion (estimated 1 day))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ryan Li, MD

Principal Investigator

OHSU Knight Cancer Institute

Study Sites (2)

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