Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

Vanessa Olbrecht

Status

Completed

Conditions

Surgery

Pain, Acute

Pain, Postoperative

Pain

Treatments

Device: Technology Based Intervention Group 2

Device: Technology Based Intervention Group 1

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04943874

5R34AT011218 (U.S. NIH Grant/Contract)

2020-0994

Details and patient eligibility

About

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

Full description

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.

Enrollment

93 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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