FOREVR Peds VR Pilot

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ClinicalTrials.gov Identifier: NCT04556747

Recruitment Status : Completed

First Posted : September 21, 2020

Last Update Posted : September 24, 2021

Sponsor:

Information provided by (Responsible Party):

Children's Hospital Medical Center, Cincinnati

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative Pain Anxiety	Other: VR - Distraction Other: VR - Biofeedback	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	111 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients (FOREVR Peds Study)
Actual Study Start Date :	September 1, 2018
Actual Primary Completion Date :	March 11, 2020
Actual Study Completion Date :	March 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
VR - Distraction	Other: VR - Distraction Participants will be instructed to use any application.
VR - Biofeedback	Other: VR - Biofeedback Participants will be instructed to use the Mindful Aurora application.

Outcome Measures

Primary Outcome Measures :

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures :

Role of anxiety on changes in pain [ Time Frame: One time prior to study visit ]
Participants will complete a questionnaire regarding anxiety
Role of pain catastrophizing [ Time Frame: One time prior to study visit ]
Participants will complete a questionnaire regarding pain

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	7 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556747

Locations

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

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

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Principal Investigator:	Vanessa Olbrecht, MD	Cincinnati Childrens Hospital Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Olbrecht VA, O'Conor KT, Williams SE, Boehmer CO, Marchant GW, Glynn SM, Geisler KJ, Ding L, Yang G, King CD. Guided Relaxation-Based Virtual Reality for Acute Postoperative Pain and Anxiety in a Pediatric Population: Pilot Observational Study. J Med Internet Res. 2021 Jul 12;23(7):e26328. doi: 10.2196/26328.

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Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT04556747
Other Study ID Numbers:	2018-2892
First Posted:	September 21, 2020 Key Record Dates
Last Update Posted:	September 24, 2021
Last Verified:	September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	This information will be made available upon request
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Time Frame:	Data will become available upon publication. All data will be deidentified.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations

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