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

NCT03220828 | Completed

• 1 other identifier: 40232
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Emotional

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score

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

  immediately post vascular access minus baseline

Secondary Outcomes (5)

• Fear Score

  immediately post vascular access minus baseline

• Family Satisfaction

  Immediatly Post Vascular Access

• Patient Satisfaction

  Immediately Post Vascular Access

• Patient Compliance

  At the time of Vascular Access

• Adverse Events

  At the time of Vascular Access

Study Arms (2)

Control

NO INTERVENTION

The control group will be provided standard of care, which is no use of technologies.

Intervention Group VR

EXPERIMENTAL

Interventional arm will use technology based distractions (Virtual Reality)

Behavioral: Technology Based Distractions

Interventions

Technology Based Distractions BEHAVIORAL

Technology based distractions (VR headsets)

Intervention Group VR

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)-

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Samuel Rodriguez, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor,Department of Anesthesiology, Perioperative and Pain Medicine

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: July 18, 2017
• Study Start: August 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)