Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain
- Conditions
- Pain, PostoperativePainPain, AcuteSurgery
- Interventions
- Device: Technology Based Intervention Group 1Device: Technology Based Intervention Group 2
- Registration Number
- NCT04943874
- Lead Sponsor
- Vanessa Olbrecht
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 93
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Technology Based Intervention 1 (Phase 1) Technology Based Intervention Group 1 - Technology Based Intervention 2 (Phase 2) Technology Based Intervention Group 2 - Technology Based Intervention 1 (Phase 2) Technology Based Intervention Group 1 -
- Primary Outcome Measures
Name Time Method Aim 1: Treatment protocol refinement Duration of study up to 30 days Duration of sessions
Aim 2: Feasibility of technology intervention in perioperative patients Pre-intervention Rate of study recruitment
- Secondary Outcome Measures
Name Time Method Aim 1: Preoperative training protocol Up to two weeks pre-operatively Duration of preoperative training session
Aim 2: Effect of technology on pain 30 minutes after using technology 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.
Aim 2: Rate of study retention Duration of study up to 30 days Assessment of ability to retain patients in pilot clinical trial
Aim 2: Effect of technology on anxiety Immediately after using technology Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Aim 2: Treatment-specific satisfaction Post intervention up to two weeks Qualitative feedback from participants using semi-structured interview to assess intervention satisfaction
Aim 1: Post-operative session protocol Up to two weeks post surgery Duration of post-operative intervention session
Aim 2: Rate of study enrollment/randomization Pre-intervention Assessment of ability to enroll and randomize patients in pilot clinical trial
Aim 2: Rate of treatment adherence Duration of study up to 30 days Assessment of patient adherence to study protocol
Aim 2: Effect of technology on medication use Duration of hospital stay (2-7 days) Medications used will be collected
Aim 2: Self-Reported Outcomes Day of hospital discharge (Postoperatively 2-7 days) Semi-structured interview
Trial Locations
- Locations (1)
Nemours Children's Hospital
🇺🇸Wilmington, Delaware, United States