Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

Feasibility and Acceptability of a Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain in Children and Adolescents After Surgery

To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.

This is a 2-phase study aimed to refine a perioperative treatment protocol for a technology-based intervention (Aim 1) and to understand whether technology-based interventions can be used to help treat pain in children following surgery (Aim 2). Patients will participate in only one phase of the study, and when patients are enrolled will determine what Phase of the study they are in.

In Phase 1, all patients will use the same technology, and no randomization will occur. Primary and secondary outcome measures of Aim 1 are assessed in Phase 1. Actual enrollment for Phase 1 was 23 patients.

In Phase 2, patients will be randomized to receive 1 of 2 technology-based interventions. The perioperative treatment protocol developed in Phase 1 (Aim 1) will be used in Phase 2 to assess the primary and secondary outcome measures of Aim 2. This phase is anticipated to enroll up to 70 participants.

This is not an FDA-regulated drug or device trial as the technology used in this study is categorized as a relaxation device by the FDA and considered "minimal risk", thus exempt from both NDE and IDE.

Inclusion Criteria:

• Ages 12 -18 years
• Scheduled to undergo surgery anticipated to cause moderate to severe pain with expected length of stay > or = to 2 days
• Able to read, understand and speak English
• Patients requiring management by the Acute Pain Service
• Possession of a mobile device/computer available for study participation

Exclusion Criteria:

• Outside the age range (< 12 or > 18 years)
• Non-English speaking
• History of significant developmental delay, uncontrolled psychiatric conditions associated with hallucinations or delusions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
• History of vertigo, dizziness, seizure disorder, and/or severe motion sickness
• History of chronic pain
• Are chronically using opioids and or benzodiazepines for the management of pain
• Are actively experiencing nausea or vomiting
• Conditions such as craniofacial abnormalities or surgeries of the head and neck
• Previous participation in this study