VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

NCT03464955 | Completed

• 1 other identifier: 42351
• Study Type: interventional
• Target: 291
• 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, 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.

Conditions

Stress, Emotional; Stress, Psychological; Behavioral Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Anxiety Score

  Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline

• Anxiety Meter

  Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline

• Family Satisfaction

  Immediately Post Non-Invasive Surgical Subspecialty Procedure

• Patient Satisfaction

  Immediately Post Non-Invasive Surgical Subspecialty Procedure

• Patient Cooperation

  At the time of Non-Invasive Surgical Subspecialty Procedure

Study Arms (3)

Control

NO INTERVENTION

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

Intervention Group with Passive Content

EXPERIMENTAL

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

Intervention Group with Active Content

EXPERIMENTAL

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

Interventions

Technology Based Distractions BEHAVIORAL

Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

Intervention Group with Active Content; Intervention Group with Passive Content

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be between ages of 2-18 years of age
• Have comprehension of instructions in the English language
• Have parental consent
• Pediatric patients must be undergoing non-invasive surgical subspecialty procedures at an Lucile Packard Children's Hospital (LPCH) out-patient clinic
• 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 \>24 hours or without the operation)
• Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
• Strong parental or patient preference for pharmacological anxiolytic
• Strong parental or patient preference for specific anxiety-reducing technique

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; Behavioral Symptoms

Condition Hierarchy (Ancestors)

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: March 7, 2018
• First Posted: March 14, 2018
• Study Start: October 16, 2017
• Primary Completion: June 30, 2023
• Study Completion: July 11, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)