FOREVR Peds VR Pilot

Not Applicable

Completed

• Conditions: Anxiety; Pain; Pain, Postoperative
• Interventions: Other: VR - Distraction; Other: VR - Biofeedback

• Registration Number: NCT04556747
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2020-03-11
• Study Completion: 2020-03-11
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR - Distraction	VR - Distraction	-
VR - Biofeedback	VR - Biofeedback	-

Primary Outcome Measures

Name	Time	Method
Effect of VR-Biofeedback on anxiety	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	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	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	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	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

Name	Time	Method
Role of anxiety on changes in pain	One time prior to study visit	Participants will complete a questionnaire regarding anxiety
Role of pain catastrophizing	One time prior to study visit	Participants will complete a questionnaire regarding pain

Trial Locations

Locations (1)

Cincinnati Childrens Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States