Clinical trial NCT04759183: Virtual Reality Experiences for Anxiety and Pain Control
Official title: Impact of Different Virtual Reality Experiences on Anxiety and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2021-02-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in preoperative anxiety scores
timeFrame: Baseline up to pre surgery (estimated 1 day)
measure: Change in postoperative pain scores
timeFrame: Baseline after surgery up to study completion (estimated 1 day)
Secondary outcomes:
measure: Change in blood pressure
timeFrame: immediately before intervention, and then immediately after intervention (estimated 1 day)
measure: Patient enjoyment of each VR experience
timeFrame: Up to study completion (estimated 1 day)
measure: Change in heart rate
timeFrame: immediately before intervention, and then immediately after intervention (estimated 1 day)
measure: Patient desire to use VR more in their healthcare
timeFrame: Up to study completion (estimated 1 day)
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Ryan J Li
role: PRINCIPAL_INVESTIGATOR
References: