Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access

Study Overview
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Brief Summary
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Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, postoperative pain, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting devices (Virtual Reality headset) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before vascular access among hospitalized children undergoing vascular access prior to anesthesia, procedures, surgery, blood draws, port access, or peripheral IV placement. The anticipated primary outcome will be reduction of child's anxiety during and after vascular access.

Detailed Description
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Anxiety among children undergoing vascular access is common. Not only is high anxiety traumatic, but research indicates that high anxiety in children before surgery leads to adverse outcomes such as increased pain and analgesics requirements, delayed hospital discharge, and maladaptive behavioral changes. Treating anxiety may decrease any of these undesirable behaviors. In this study, investigators hope to determine if technology based distractions (VR headsets) are more effective than standard care for preventing high anxiety before vascular access. As a secondary aim of the study, we seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction, decreased fear, and increased compliance, while monitoring for side-effects of the intervention.

Official Title
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Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access

Conditions
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Stress, Emotional

Intervention / Treatment
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* Behavioral: Technology Based Distractions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be between ages of 7-18 years of age have comprehension of instructions in the English language have parental consent Pediatric patient must be undergoing non-emergent vascular access at Lucile Packard Children's Hospital in one of the 6 previously defined care areas (please see study design in Section 16). Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)- Exclusion Criteria: Significant cognitive impairment/developmental delays per parental report or H&P. Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive >24hours or without the operation) H/o severe motion sickness, nausea, seizures

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group will be provided standard of care, which is no use of technologies. | |
| Experimental: Intervention Group VR<br>Interventional arm will use technology based distractions (Virtual Reality) | Behavioral: Technology Based Distractions<br>* Technology based distractions (VR headsets)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Score | Peak Pain Score minus Baseline Pain Score(0-10) | immediately post vascular access minus baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear Score | Fear Faces | immediately post vascular access minus baseline | 
| Family Satisfaction | Family Satisfaction Survey | Immediatly Post Vascular Access | 
| Patient Satisfaction | Patient Satisfaction Survey | Immediately Post Vascular Access | 
| Patient Compliance | Modified Induction Compliance Checklist | At the time of Vascular Access | 
| Adverse Events | Negative outcomes such as nausea, headache | At the time of Vascular Access |