Clinical trial NCT03220828: Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access
Official title: Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Emotional
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 220
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Score
timeFrame: immediately post vascular access minus baseline
Secondary outcomes:
measure: Fear Score
timeFrame: immediately post vascular access minus baseline
measure: Family Satisfaction
timeFrame: Immediatly Post Vascular Access
measure: Patient Satisfaction
timeFrame: Immediately Post Vascular Access
measure: Patient Compliance
timeFrame: At the time of Vascular Access
measure: Adverse Events
timeFrame: At the time of Vascular Access
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Samuel Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: