Skip to main content
OpenTrials
Completed

NCT Number: NCT03220828

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be between ages of 7-18 years of age
  • have comprehension of instructions in the English language
  • have parental consent
  • 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).
  • Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)-

Exclusion criteria

  • Significant cognitive impairment/developmental delays per parental report or H&P.
  • 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)
  • H/o severe motion sickness, nausea, seizures

Treatment and study plan

Technology Based Distractions

Behavioral

Technology based distractions (VR headsets)

Primary outcomes

  1. Change in Pain Score

    Time frame: immediately post vascular access minus baseline

    Peak Pain Score minus Baseline Pain Score(0-10)

Secondary outcomes

  1. Fear Score

    Time frame: immediately post vascular access minus baseline

    Fear Faces

  2. Family Satisfaction

    Time frame: Immediatly Post Vascular Access

    Family Satisfaction Survey

  3. Patient Satisfaction

    Time frame: Immediately Post Vascular Access

    Patient Satisfaction Survey

  4. Patient Compliance

    Time frame: At the time of Vascular Access

    Modified Induction Compliance Checklist

  5. Adverse Events

    Time frame: At the time of Vascular Access

    Negative outcomes such as nausea, headache

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.