Technology-Based Distractions During Minor Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.

Official Title
-----------------
Evaluation of Technology-Based Distractions In Pediatric Patients During Minor Procedures

Conditions
-----------------
Pain, Anxiety, Procedural Anxiety

Intervention / Treatment
-----------------
* Behavioral: Use of Virtual Technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 17 and under Able to consent or have parental consent Undergoing minor procedures (i.e lumbar punctures, cardiac catheterization) at Lucile Packard Children's Hospital (LPCH) or Stanford Hospital facilities Exclusion Criteria: People who do not consent Significant Cognitive Impairment History of Severe Motion Sickness Current Nausea Seizures Visual Problems Non-English Speaking Patients who clinically unstable or requires urgent/emergent intervention (ASA) Physical status classification class 4 or higher Patient or parental preference for General Anesthesia

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Cathertization Patients<br>Participants will use technology based distraction during procedure. | Behavioral: Use of Virtual Technology<br>* If parent and child consent to be in the study, the clinician will offer the use of one of the technologies: Virtual Reality (VR) headset or Augmented Reality (AR) headset. Active content includes video games, interactive avatars, and interactive experiences, while passive content includes video clips and movies. All patients will be offered the opportunity to use these technologies during their minor procedures if they meet eligibility criteria. Those who decline or who are switched over to the standard of care due to patient preference, health providers monitoring and assessment during the procedure will be noted in the database.<br>|
| Experimental: Allergy Patients<br>Participants will use technology based distraction during procedure | Behavioral: Use of Virtual Technology<br>* If parent and child consent to be in the study, the clinician will offer the use of one of the technologies: Virtual Reality (VR) headset or Augmented Reality (AR) headset. Active content includes video games, interactive avatars, and interactive experiences, while passive content includes video clips and movies. All patients will be offered the opportunity to use these technologies during their minor procedures if they meet eligibility criteria. Those who decline or who are switched over to the standard of care due to patient preference, health providers monitoring and assessment during the procedure will be noted in the database.<br>|
| No Intervention: Procedure-Only Patients<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure anxiety score | Numerical anxiety scale (0-10), 0 being no anxiety and 10 being the worst imaginable anxiety | Duration of procedure (usually no more than 2-4 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent and Child Satisfaction Questionnaire | Parent and child questionnaire with 5 questions asking the individual on a scale from 1-5 how much they agree with each statement (1=Not at all, 3=A little bit, 5=A lot). It has stamens such as Having the technology made me feel more relaxed before my procedure or If I ever have procedure again, I would like to use this technology | Duration of procedure (usually no more than 2-4 hours) | 
| Virtual and Augmented Reality Feedback Survey | Measure satisfaction and feedback for Virtual Reality/ Augmented Reality in regards to software and hardware for future iterations. | Duration of procedure (usually no more than 2-4 hours) | 
| Asses cumulative medication dosing and the duration of procedure | Measure dosing requirements for anxiolytic and/or analgesic medications for participants thought their procedure. We will then compare these doses to their own historical chart data, since many of these patents come in routinely, and use their own data for intra-reliability measures. | Duration of procedure (usually no more than 2-4 hours) | 
| Evaluation of Passive vs Active Interventions | There is variation in the immersive technology experiences (active vs passive content), as a part of the study the investigators also aim to evaluate the degree of cognitive load which is suitable for clinical applications during minor procedures. During the participants immersive experience in either AR or VR, there are embedded questions in the experience that can gage as to the patient's emotional status (happy, sad, mad) or VAS scales (0-10, 0=no pain, 10=worst imaginable pain) that can let the research personnel know if we need to increase the cognitive load. If patients are self-reporting higher VAS scores, or aversive emotional status (i.e mad) the cognitive load will be increased to enhance the distraction experience from the procedure. | Duration of procedure (usually no more than 2-4 hours) |