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OpenTrials
Completed

NCT Number: NCT04759183

Virtual Reality Experiences for Anxiety and Pain Control

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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Ancillary studies

Virtual Reality Game

Procedure

Participate in VR Game "Angry Birds"

Other names: VR Game

Virtual Reality Meditation

Procedure

Participate in VR Meditation "TRIPP"

Other names: VR Meditation

Primary outcomes

  1. Change in preoperative anxiety scores

    Time frame: Baseline up to pre surgery (estimated 1 day)

    Assessed by visual analogue scale (VAS) from 0-100mm.

  2. Change in postoperative pain scores

    Time frame: Baseline after surgery up to study completion (estimated 1 day)

    Assessed by VAS scale from 0-100mm.

Secondary outcomes

  1. Change in blood pressure

    Time frame: immediately before intervention, and then immediately after intervention (estimated 1 day)

    mmHg

  2. Patient enjoyment of each VR experience

    Time frame: Up to study completion (estimated 1 day)

    Likert scale (1-5). 1 represents the lowest score, and 5 represents the highest.

  3. Change in heart rate

    Time frame: immediately before intervention, and then immediately after intervention (estimated 1 day)

    beats per minute (bpm)

  4. Patient desire to use VR more in their healthcare

    Time frame: Up to study completion (estimated 1 day)

    Likert scale (1-5). 1 represents the lowest score, and 5 represents the highest.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

Impact of Different Virtual Reality Experiences on Anxiety and Pain

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2021
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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