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

Stress, Emotional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220828
• Other study ID #: 40232
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Stress, Emotional
• Stress, Psychological

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