FOREVR Peds VR Pilot

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: Completed
• Conditions: Pain; Pain, Postoperative; Anxiety
• Intervention / Treatment: Other: VR - Distraction; Other: VR - Biofeedback

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Effect of VR-distraction on anxiety	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Role of anxiety on changes in pain	Participants will complete a questionnaire regarding anxiety	One time prior to study visit
Role of pain catastrophizing	Participants will complete a questionnaire regarding pain	One time prior to study visit

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Vanessa Olbrecht, MD, Cincinnati Childrens Hospital Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): March 11, 2020
• Study Completion (ACTUAL): March 11, 2020

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (ACTUAL): September 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID 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