FOREVR Peds VR Pilot

September 23, 2021 updated by: Children's Hospital Medical Center, Cincinnati

Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients (FOREVR Peds Study)

To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Childrens Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 7to 21 years
  • Able to read, understand, and speak English
  • Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list.
  • Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis

Exclusion Criteria:

  • Outside the age range (< 7 or > 21 years)
  • History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
  • History of vertigo, dizziness, and/or seizure disorder
  • Conditions that would preclude the application of the VR glasses, such as surgeries of the head and neck

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: VR - Distraction
Other: VR - Distraction
Participants will be instructed to use any application.
OTHER: VR - Biofeedback
Other: VR - Biofeedback
Participants will be instructed to use the Mindful Aurora application.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect of VR-distraction on anxiety
Time Frame: Before 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Before 10 minute VR session.
Effect of VR-Distraction on anxiety
Time Frame: Immediately after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Immediately after 10 minute VR session.
Effect of VR-Distraction on anxiety
Time Frame: 15 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
15 minutes after 10 minute VR session.
Effect of VR-Distraction on anxiety
Time Frame: 30 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
30 minutes after 10 minute VR session.
Effect of VR-Distraction on pain
Time Frame: Before 10 minute VR session.
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Before 10 minute VR session.
Effect of VR-Distraction on pain
Time Frame: Immediately after 10 minute VR session.
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Immediately after 10 minute VR session.
Effect of VR-Distraction on pain
Time Frame: 15 minutes after 10 minute VR session.
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
15 minutes after 10 minute VR session.
Effect of VR-Distraction on pain
Time Frame: 30 minutes after 10 minute VR session.
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
30 minutes after 10 minute VR session.
Effect of VR-Biofeedback on anxiety
Time Frame: Before 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Before 10 minute VR session.
Effect of VR-Biofeedback on anxiety
Time Frame: Immediately after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Immediately after 10 minute VR session.
Effect of VR-Biofeedback on anxiety
Time Frame: 15 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
15 minutes after 10 minute VR session.
Effect of VR-Biofeedback on anxiety
Time Frame: 30 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
30 minutes after 10 minute VR session.
Effect of VR-Biofeedback on pain
Time Frame: Before 10 minute VR session
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Before 10 minute VR session
Effect of VR-Biofeedback on pain
Time Frame: Immediately after 10 minute VR session
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Immediately after 10 minute VR session
Effect of VR-Biofeedback on pain
Time Frame: 15 minutes after 10 minute VR session
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
15 minutes after 10 minute VR session
Effect of VR-Biofeedback on pain
Time Frame: 30 minutes after 10 minute VR session
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
30 minutes after 10 minute VR session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Role of anxiety on changes in pain
Time Frame: One time prior to study visit
Participants will complete a questionnaire regarding anxiety
One time prior to study visit
Role of pain catastrophizing
Time Frame: One time prior to study visit
Participants will complete a questionnaire regarding pain
One time prior to study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vanessa Olbrecht, MD, Cincinnati Childrens Hospital Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-2892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This information will be made available upon request

IPD Sharing Time Frame

Data will become available upon publication. All data will be deidentified.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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