FOREVR Peds VR Pilot

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Pain, Postoperative; Anxiety; Pain

Treatments: Other: VR - Biofeedback; Other: VR - Distraction

Study type: Interventional

Funder types: Other

Identifiers

NCT04556747

2018-2892

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 7 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

VR - Distraction

Other group

Treatment:

Other: VR - Distraction

VR - Biofeedback

Other group

Treatment:

Other: VR - Biofeedback