Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2025-08-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain Pain, Postoperative Pain, Acute Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Technology Based Intervention 1 (Phase 1)

Group Type OTHER

Technology Based Intervention Group 1

Intervention Type DEVICE

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 1 (Phase 2)

Group Type OTHER

Technology Based Intervention Group 1

Intervention Type DEVICE

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 2 (Phase 2)

Group Type OTHER

Technology Based Intervention Group 2

Intervention Type DEVICE

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.

Interventions

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Technology Based Intervention Group 1

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.

Intervention Type DEVICE

Technology Based Intervention Group 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No