VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

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

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.

Study Overview

• Status: Completed
• Conditions: Behavioral Symptoms; Stress, Psychological; Stress, Emotional
• Intervention / Treatment: Behavioral: Technology Based Distractions

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.

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital at Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Technology Based Distractions; Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)
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.	Behavioral: Technology Based Distractions; Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Score	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.	Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Score	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.	Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Anxiety Meter	Childhood Anxiety Meter	Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Family Satisfaction	Family Satisfaction Survey	Immediately Post Non-Invasive Surgical Subspecialty Procedure
Patient Satisfaction	Patient Satisfaction Survey	Immediately Post Non-Invasive Surgical Subspecialty Procedure
Patient Cooperation	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.	At the time of Non-Invasive Surgical Subspecialty Procedure
Patient Compliance	Modified Induction Compliance Checklist	At the time of Non-Invasive Surgical Subspecialty Procedure
Parent Pain Catastrophizing Scale (PCS-P)	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.	Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Samuel Rodriguez, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stress, Psychological; Behavioral Symptoms
• Other Study ID Numbers: 42351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No