Clinical trial NCT04943874: Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain
Official title: Feasibility and Acceptability of a Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain in Children and Adolescents After Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain
Pain, Postoperative
Pain, Acute
Surgery
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-06-29
Enrollment: 93
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Aim 1: Treatment protocol refinement
timeFrame: Duration of study up to 30 days
measure: Aim 1: Treatment protocol refinement
timeFrame: Duration of study up to 30 days
measure: Aim 2: Feasibility of technology intervention in perioperative patients
timeFrame: Pre-intervention
Secondary outcomes:
measure: Aim 1: Preoperative training protocol
timeFrame: Up to two weeks pre-operatively
measure: Aim 1: Preoperative training protocol
timeFrame: Up to two weeks pre-operatively
measure: Aim 1: Post-operative session protocol
timeFrame: Up to two week post surgery
measure: Aim 1: Post-operative session protocol
timeFrame: Up to two weeks post surgery
measure: Aim 2: Rate of study enrollment/randomization
timeFrame: Pre-intervention
measure: Aim 2: Rate of study retention
timeFrame: Duration of study up to 30 days
measure: Aim 2: Rate of treatment adherence
timeFrame: Duration of study up to 30 days
measure: Aim 2: Treatment-specific satisfaction
timeFrame: Post intervention up to two weeks
measure: Aim 2: Treatment-specific satisfaction
timeFrame: Post intervention up to two weeks
measure: Aim 2: Effect of technology on anxiety
timeFrame: 30 minutes after using technology
measure: Aim 2: Effect of technology on medication use
timeFrame: Duration of hospital stay (2-7 days)
measure: Aim 2: Effect of technology on anxiety
timeFrame: Before using technology
measure: Aim 2: Effect of technology on anxiety
timeFrame: Immediately after using technology
measure: Aim 2: Effect of technology on pain
timeFrame: Preoperatively (up to 5 days)
measure: Aim 2: Effect of technology on pain
timeFrame: Before using technology
measure: Aim 2: Effect of technology on pain
timeFrame: Immediately after using technology
measure: Aim 2: Effect of technology on pain
timeFrame: 30 minutes after using technology
measure: Aim 2: Self-Reported Outcomes
timeFrame: Day of hospital discharge (Postoperatively 2-7 days)
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Hospital
state: Delaware
Study officials:
affiliation: Nemours Children's Hospital
name: Vanessa Olbrecht, MD
role: PRINCIPAL_INVESTIGATOR
References: