NCT03464955

VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting device (Virtual Reality (VR) headset, Augmented Reality (AR) headset, or bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before non-invasive surgical sub-specialty procedures among children during out-patient clinic visits. Examples of the most common procedures include, but are not limited to gastrostomy tube exchanges, suture removals, dressing changes, foley insertions, EEG set up, chest tube removals, cast removals, pin removals and other similar procedures. (The investigators refer to these procedures under an umbrella term of non-invasive surgical subspecialty procedures). The anticipated primary outcome will be reduction of child's anxiety during and after procedures.

Detailed description

Anxiety among children undergoing non-invasive surgical subspecialty procedures is common. Not only is high anxiety traumatic, but research in a surgical setting 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 that may arise when experiencing a non-invasive surgical subspecialty procedure in a clinical setting. In this study, investigators hope to determine if technology based distractions (VR headsets with headphones, AR headset, or BERT projector) are more effective than standard care for preventing high anxiety before non-invasive surgical subspecialty procedures. As a secondary objective of the study, the investigators seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction as well as evaluate which techniques are most effective. As a tertiary aim, the investigators seek to understand if passive or active interventions are more effective in decreasing anxiety.

Conditions

• Stress, Emotional
• Stress, Psychological
• Behavioral Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Technology Based Distractions	Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

Timeline

• Start date: 2017-10-16
• Primary completion: 2023-06-30
• Completion: 2023-07-11
• First posted: 2018-03-14
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States