Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304, United States
NCT Number: NCT03220828
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.
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Notify Me7 year–18 year
All sexes
Interventional
Not applicable
Palo Alto, California, 94304, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Technology based distractions (VR headsets)
Time frame: immediately post vascular access minus baseline
Peak Pain Score minus Baseline Pain Score(0-10)
Time frame: immediately post vascular access minus baseline
Fear Faces
Time frame: Immediatly Post Vascular Access
Family Satisfaction Survey
Time frame: Immediately Post Vascular Access
Patient Satisfaction Survey
Time frame: At the time of Vascular Access
Modified Induction Compliance Checklist
Time frame: At the time of Vascular Access
Negative outcomes such as nausea, headache
Stanford University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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