Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

Study Overview
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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.

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.

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

Conditions
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Pain, Pain, Postoperative, Pain, Acute, Surgery

Intervention / Treatment
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* Device: Technology Based Intervention Group 1
* Device: Technology Based Intervention Group 2


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Technology Based Intervention 1 (Phase 1)<br> | Device: Technology Based Intervention Group 1<br>* 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.<br>|
| Other: Technology Based Intervention 1 (Phase 2)<br> | Device: Technology Based Intervention Group 1<br>* 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.<br>|
| Other: Technology Based Intervention 2 (Phase 2)<br> | Device: Technology Based Intervention Group 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aim 1: Treatment protocol refinement | Frequency of sessions | Duration of study up to 30 days | 
| Aim 1: Treatment protocol refinement | Duration of sessions | Duration of study up to 30 days | 
| Aim 2: Feasibility of technology intervention in perioperative patients | Rate of study recruitment | Pre-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aim 1: Preoperative training protocol | Frequency of preoperative training session | Up to two weeks pre-operatively | 
| Aim 1: Preoperative training protocol | Duration of preoperative training session | Up to two weeks pre-operatively | 
| Aim 1: Post-operative session protocol | Frequency of post-operative intervention session | Up to two week post surgery | 
| Aim 1: Post-operative session protocol | Duration of post-operative intervention session | 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 | Pre-intervention | 
| Aim 2: Rate of study retention | Assessment of ability to retain patients in pilot clinical trial | Duration of study up to 30 days | 
| Aim 2: Rate of treatment adherence | Assessment of patient adherence to study protocol | Duration of study up to 30 days | 
| Aim 2: Treatment-specific satisfaction | Qualitative feedback from participants using questionnaire to assess intervention satisfaction | Post intervention up to two weeks | 
| Aim 2: Treatment-specific satisfaction | Qualitative feedback from participants using semi-structured interview to assess intervention satisfaction | Post intervention up to two weeks | 
| Aim 2: Effect of technology on anxiety | Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety. | 30 minutes after using technology | 
| Aim 2: Effect of technology on medication use | Medications used will be collected | Duration of hospital stay (2-7 days) | 
| Aim 2: Effect of technology on anxiety | Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety. | Before using technology | 
| Aim 2: Effect of technology on anxiety | Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety. | Immediately after using technology | 
| Aim 2: Effect of technology on pain | Pains scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. | Preoperatively (up to 5 days) | 
| Aim 2: Effect of technology on pain | Pains scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. | Before using technology | 
| Aim 2: Effect of technology on pain | Pains scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. | Immediately after using technology | 
| Aim 2: Effect of technology on pain | Pains scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. | 30 minutes after using technology | 
| Aim 2: Self-Reported Outcomes | Semi-structured interview | Day of hospital discharge (Postoperatively 2-7 days) |