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

NCT ID: NCT03220828

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-03-31

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.

Conditions

Stress, Emotional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group VR

Interventional arm will use technology based distractions (Virtual Reality)

Group Type: EXPERIMENTAL

Technology Based Distractions

Intervention Type: BEHAVIORAL

Technology based distractions (VR headsets)

Interventions

Technology Based Distractions

Technology based distractions (VR headsets)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Samuel Rodriguez

Assistant Professor,Department of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, United States

Countries

United States

Other Identifiers

40232

Identifier Type: -

Identifier Source: org_study_id