Virtual Reality Experiences for Anxiety and Pain Control

Not Applicable

Completed

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

• Registration Number: NCT04759183
• Lead Sponsor: OHSU Knight Cancer Institute

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 Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-18
• Study Start: 2021-03-05
• Primary Completion: 2022-04-11
• Study Completion: 2022-08-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-04
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in postoperative pain scores	Baseline after surgery up to study completion (estimated 1 day)	Assessed by VAS scale from 0-100mm.
Change in preoperative anxiety scores	Baseline up to pre surgery (estimated 1 day)	Assessed by visual analogue scale (VAS) from 0-100mm.

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	immediately before intervention, and then immediately after intervention (estimated 1 day)	mmHg
Patient enjoyment of each VR experience	Up to study completion (estimated 1 day)	Likert scale (1-5). 1 represents the lowest score, and 5 represents the highest.
Change in heart rate	immediately before intervention, and then immediately after intervention (estimated 1 day)	beats per minute (bpm)
Patient desire to use VR more in their healthcare	Up to study completion (estimated 1 day)	Likert scale (1-5). 1 represents the lowest score, and 5 represents the highest.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States