FOREVR Peds VR Pilot

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556747
• Other study ID #: 2018-2892
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 11, 2020

Study information

• Verified date: September 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain
• Pain, Postoperative

Intervention

Other:
• VR - Distraction
Participants will be instructed to use any application.
• VR - Biofeedback
Participants will be instructed to use the Mindful Aurora application.

Locations

Country	Name	City	State
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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	Role of anxiety on changes in pain	Participants will complete a questionnaire regarding anxiety	One time prior to study visit
Secondary	Role of pain catastrophizing	Participants will complete a questionnaire regarding pain	One time prior to study visit