Stress, Emotional
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALTechnology Based Distractions
Technology based distractions (VR headsets)
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. be between ages of 7-18 years of age 2. have comprehension of instructions in the English language 3. have parental consent 4. 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). 5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)-
Exclusion criteria
1. Significant cognitive impairment/developmental delays per parental report or H&P. 2. 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) 3. H/o severe motion sickness, nausea, seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | immediately post vascular access minus baseline | Peak Pain Score minus Baseline Pain Score(0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear Score | immediately post vascular access minus baseline | Fear Faces |
| Family Satisfaction | Immediatly Post Vascular Access | Family Satisfaction Survey |
| Patient Satisfaction | Immediately Post Vascular Access | Patient Satisfaction Survey |
| Patient Compliance | At the time of Vascular Access | Modified Induction Compliance Checklist |
| Adverse Events | At the time of Vascular Access | Negative outcomes such as nausea, headache |
Countries
United States
Outcome results
None listed