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Clinical Trials/NCT04556747
NCT04556747
Completed
N/A

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

Children's Hospital Medical Center, Cincinnati1 site in 1 country111 target enrollmentSeptember 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
111
Locations
1
Primary Endpoint
Effect of VR-Biofeedback on anxiety
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
March 11, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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-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: 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-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-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 Outcomes

  • Role of anxiety on changes in pain(One time prior to study visit)
  • Role of pain catastrophizing(One time prior to study visit)

Study Sites (1)

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