Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

Vanessa Olbrecht93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Pain Pain, Postoperative Pain, Acute Surgery

Interventions

Technology Based Intervention Group 1DEVICE

In Phase 1, all participants will use the same technology. In Phase 2, participants will be blinded to the two specific groups. They will not be aware of the technology used in the group they are not assigned too.

Technology Based Intervention Group 2DEVICE

Participants will be blinded to the two specific groups. They will not be aware of the technology used in the group they are not assigned too.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nemours Children's Hospital

Wilmington, Delaware, United States

Outcomes

Primary Outcomes

Aim 1: Treatment protocol refinement

Frequency of sessions

Time frame: Duration of study up to 30 days

Aim 1: Treatment protocol refinement

Duration of sessions

Time frame: Duration of study up to 30 days

Aim 2: Feasibility of technology intervention in perioperative patients

Rate of study recruitment

Time frame: Pre-intervention

Secondary Outcomes

Aim 1: Preoperative training protocol

Frequency of preoperative training session

Time frame: Up to two weeks pre-operatively

Aim 1: Preoperative training protocol

Duration of preoperative training session

Time frame: Up to two weeks pre-operatively

Aim 1: Post-operative session protocol

Frequency of post-operative intervention session

Time frame: Up to two week post surgery

Aim 1: Post-operative session protocol

Duration of post-operative intervention session

Time frame: Up to two weeks post surgery

Aim 2: Rate of study enrollment/randomization

Assessment of ability to enroll and randomize patients in pilot clinical trial

Time frame: Pre-intervention

Aim 2: Rate of study retention

Data from ClinicalTrials.gov

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