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

Not Applicable

Completed

• Conditions: Stress, Emotional
• Interventions: Behavioral: Technology Based Distractions

• Registration Number: NCT03220828
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-18
• Study Start: 2017-08-01
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group VR	Technology Based Distractions	Interventional arm will use technology based distractions (Virtual Reality)

Primary Outcome Measures

Name	Time	Method
Change in Pain Score	immediately post vascular access minus baseline	Peak Pain Score minus Baseline Pain Score(0-10)

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	Immediately Post Vascular Access	Patient Satisfaction Survey
Family Satisfaction	Immediatly Post Vascular Access	Family 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
Fear Score	immediately post vascular access minus baseline	Fear Faces

Trial Locations

Locations (1)

Lucile Packard Children's Hospital at Stanford; 🇺🇸 Palo Alto, California, United States