VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

Overview

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.

Full Title of Study: “Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 16, 2019

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.

Interventions

  • Behavioral: Technology Based Distractions
    • Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

Arms, Groups and Cohorts

  • No Intervention: Control
    • The control group will be provided standard of care, which is no use of technologies.
  • Experimental: Intervention Group with Passive Content
    • Interventional arm will use technology based distractions (VR headsets, AR headset, tablets, or BERT projector) to prevent high anxiety before non-invasive surgical subspecialty procedures.
  • Experimental: Intervention Group with Active Content
    • Interventional arm will use technology based distractions (VR headsets, AR headset, tablets, or BERT projector) to prevent high anxiety before non-invasive surgical subspecialty procedures.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Pain Score
    • Time Frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
    • Peak Pain Score minus Baseline Pain Score. Pain scores range from 0 to 10. 0 represents no pain and 10 represents the worst pain possible. Change in pain score ranges from +10 to -10. Higher positive values represent a worse outcome, and higher negative values represent a better outcome.

Secondary Measures

  • Anxiety Score
    • Time Frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
    • Fear Faces. Images of faces depicting increasing levels of fear measure the degree of fear the patient is experiencing. Faces correlate to a score ranging from 0 to 4. 0 represents the least scared and 4 represents the most scared. Higher values represent a worse outcome.
  • Anxiety Meter
    • Time Frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
    • Childhood Anxiety Meter
  • Family Satisfaction
    • Time Frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure
    • Family Satisfaction Survey
  • Patient Satisfaction
    • Time Frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure
    • Patient Satisfaction Survey
  • Patient Cooperation
    • Time Frame: At the time of Non-Invasive Surgical Subspecialty Procedure
    • Brief Behavioral Distress Scale (BBDS). Measures patient cooperation. Behavior cooperation choices exist on a scale consisting of non-interfering behaviors, potentially-interfering behaviors and interfering behaviors. Non-Interfering Behaviors = minor, verbal/vocal distress, moan, comfort seeking, etc. Potentially Interfering Behaviors = intense verbal/vocal distress, scream, shout, tensing of muscles, clench, flinch, gritting of teeth, etc.Interfering Behaviors = escape, disrupt, avoid, aggress, etc. Interfering behaviors represent a worse outcome.
  • Patient Compliance
    • Time Frame: At the time of Non-Invasive Surgical Subspecialty Procedure
    • Modified Induction Compliance Checklist
  • Parent Pain Catastrophizing Scale (PCS-P)
    • Time Frame: Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure
    • PCS-P. Measures the extent of thought concerning pain Scale ranges from 1 to 5. 1 represents not thinking at all about pain and 5 represents thinking very much about pain. Higher values represent a worse outcome.

Participating in This Clinical Trial

Inclusion Criteria

1. Be between ages of 2-18 years of age

2. Have comprehension of instructions in the English language

3. Have parental consent

4. Pediatric patients must be undergoing non-invasive surgical subspecialty procedures at an Lucile Packard Children's Hospital (LPCH) out-patient clinic

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 >24 hours or without the operation)

3. Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation

4. Strong parental or patient preference for pharmacological anxiolytic

5. Strong parental or patient preference for specific anxiety-reducing technique

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Samuel Rodriguez, Assistant Professor, Department of Anesthesiology, Perioperative and Pain Medicine – Stanford University
  • Overall Official(s)
    • Samuel Rodriguez, MD, Principal Investigator, Stanford University
  • Overall Contact(s)
    • Samuel Rodriguez, MD, 650-723-5728, sr1@stanford.edu

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