Clinical trial NCT04556747: FOREVR Peds VR Pilot
Official title: Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients (FOREVR Peds Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Pain
Anxiety
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 111
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Effect of VR-distraction on anxiety
timeFrame: Before 10 minute VR session.
measure: Effect of VR-Distraction on anxiety
timeFrame: Immediately after 10 minute VR session.
measure: Effect of VR-Distraction on anxiety
timeFrame: 15 minutes after 10 minute VR session.
measure: Effect of VR-Distraction on anxiety
timeFrame: 30 minutes after 10 minute VR session.
measure: Effect of VR-Distraction on pain
timeFrame: Before 10 minute VR session.
measure: Effect of VR-Distraction on pain
timeFrame: Immediately after 10 minute VR session.
measure: Effect of VR-Distraction on pain
timeFrame: 15 minutes after 10 minute VR session.
measure: Effect of VR-Distraction on pain
timeFrame: 30 minutes after 10 minute VR session.
measure: Effect of VR-Biofeedback on anxiety
timeFrame: Before 10 minute VR session.
measure: Effect of VR-Biofeedback on anxiety
timeFrame: Immediately after 10 minute VR session.
measure: Effect of VR-Biofeedback on anxiety
timeFrame: 15 minutes after 10 minute VR session.
measure: Effect of VR-Biofeedback on anxiety
timeFrame: 30 minutes after 10 minute VR session.
measure: Effect of VR-Biofeedback on pain
timeFrame: Before 10 minute VR session
measure: Effect of VR-Biofeedback on pain
timeFrame: Immediately after 10 minute VR session
measure: Effect of VR-Biofeedback on pain
timeFrame: 15 minutes after 10 minute VR session
measure: Effect of VR-Biofeedback on pain
timeFrame: 30 minutes after 10 minute VR session
Secondary outcomes:
measure: Role of anxiety on changes in pain
timeFrame: One time prior to study visit
measure: Role of pain catastrophizing
timeFrame: One time prior to study visit
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Childrens Hospital Medical Center
name: Vanessa Olbrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.