Virtual Reality Experiences for Anxiety and Pain Control

Impact of Different Virtual Reality Experiences on Anxiety and Pain

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Procedure: Virtual Reality Game; Procedure: Virtual Reality Meditation

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: Interventional
• Enrollment (Actual): 32
• 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: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

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.	Other: Survey Administration; Ancillary studies; Procedure: Virtual Reality Game; Participate in VR Game "Angry Birds"; Other Names: VR Game; Procedure: Virtual Reality Meditation; Participate in VR Meditation "TRIPP"; Other Names: 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 Names: VR Game; Procedure: Virtual Reality Meditation; Participate in VR Meditation "TRIPP"; Other Names: VR Meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in preoperative anxiety scores	Assessed by visual analogue scale (VAS) from 0-100mm.	Baseline up to pre surgery (estimated 1 day)
Change in postoperative pain scores	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	mmHg	immediately before intervention, and then immediately after intervention (estimated 1 day)
Patient enjoyment of each VR experience	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	beats per minute (bpm)	immediately before intervention, and then immediately after intervention (estimated 1 day)
Patient desire to use VR more in their healthcare	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: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Ryan J Li, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• 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: No
• Studies a U.S. FDA-regulated device product: No