NCT04759183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

February 12, 2021

Last Update Submit

September 4, 2022

Conditions

Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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)

Study Arms (2)

Arm I (Angry Birds, TRIPP)

EXPERIMENTAL

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 AdministrationProcedure: Virtual Reality GameProcedure: Virtual Reality Meditation

Arm II (TRIPP, Angry Birds)

EXPERIMENTAL

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 AdministrationProcedure: Virtual Reality GameProcedure: Virtual Reality Meditation

Interventions

Survey AdministrationOTHER

Ancillary studies

Arm I (Angry Birds, TRIPP)Arm II (TRIPP, Angry Birds)
Virtual Reality GamePROCEDURE

Participate in VR Game "Angry Birds"

Also known as: VR Game
Arm I (Angry Birds, TRIPP)Arm II (TRIPP, Angry Birds)
Virtual Reality MeditationPROCEDURE

Participate in VR Meditation "TRIPP"

Also known as: VR Meditation
Arm I (Angry Birds, TRIPP)Arm II (TRIPP, Angry Birds)

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18 years or older and younger than 89)
  • Able to consent
  • English-speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ryan J Li

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 18, 2021

Study Start

March 5, 2021

Primary Completion

April 11, 2022

Study Completion

August 25, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

US(1)