Virtual Reality and Pain (FOREVR Peds)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Pain, Postoperative; Anxiety Postoperative; Pain

Treatments: Other: VR-Distraction; Other: 360 Video; Other: VR-Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04351776

2019-1090

Details and patient eligibility

About

Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery.

Enrollment: 90 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 8 - 18 years
• Able to read, understand and speak English
• Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service

Exclusion criteria

• Outside the age range (< 8 or > 18 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 headset, such as surgeries of the head and neck

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

VR-Biofeedback

Other group

Treatment:

Other: VR-Biofeedback

VR-Distraction

Other group

Treatment:

Other: VR-Distraction

360 Video

Other group

Treatment:

Other: 360 Video