Virtual Reality Experiences for Anxiety and Pain Control

Malignant Solid Neoplasm Clinical Trial

Official title:

Impact of Different Virtual Reality Experiences on Anxiety and Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759183
• Other study ID #: STUDY00022194
• Secondary ID: NCI-2021-00794ST
• Status: Completed
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: August 25, 2022

Study information

• Verified date: September 2022
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 25, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Survey Administration
Ancillary studies

Procedure:
• Virtual Reality Game
Participate in VR Game "Angry Birds"
• Virtual Reality Meditation
Participate in VR Meditation "TRIPP"

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in preoperative anxiety scores	Assessed by visual analogue scale (VAS) from 0-100mm.	Baseline up to pre surgery (estimated 1 day)
Primary	Change in postoperative pain scores	Assessed by VAS scale from 0-100mm.	Baseline after surgery up to study completion (estimated 1 day)
Secondary	Change in blood pressure	mmHg	immediately before intervention, and then immediately after intervention (estimated 1 day)
Secondary	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)
Secondary	Change in heart rate	beats per minute (bpm)	immediately before intervention, and then immediately after intervention (estimated 1 day)
Secondary	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)