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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03220828
Other study ID # 40232
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date March 31, 2019

Study information

Verified date April 2019
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Technology Based Distractions
Technology based distractions (VR headsets)

Locations

Country Name City State
United States Lucile Packard Children's Hospital at Stanford Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pain Score Peak Pain Score minus Baseline Pain Score(0-10) immediately post vascular access minus baseline
Secondary Fear Score Fear Faces immediately post vascular access minus baseline
Secondary Family Satisfaction Family Satisfaction Survey Immediatly Post Vascular Access
Secondary Patient Satisfaction Patient Satisfaction Survey Immediately Post Vascular Access
Secondary Patient Compliance Modified Induction Compliance Checklist At the time of Vascular Access
Secondary Adverse Events Negative outcomes such as nausea, headache At the time of Vascular Access
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