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VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

Primary Purpose

Stress, Emotional, Stress, Psychological, Behavioral Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology Based Distractions
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Emotional

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lucile Packard Children's Hospital at Stanford

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Intervention Group with Passive Content

Intervention Group with Active Content

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Anxiety Meter
Childhood Anxiety Meter
Family Satisfaction
Family Satisfaction Survey
Patient Satisfaction
Patient Satisfaction Survey
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.
Patient Compliance
Modified Induction Compliance Checklist
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.

Full Information

First Posted
March 7, 2018
Last Updated
September 25, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03464955
Brief Title
VR Usage in Non-Invasive Surgical Sub-Specialty Procedures
Official Title
Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Emotional, Stress, Psychological, Behavioral Symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will be provided standard of care, which is no use of technologies.
Arm Title
Intervention Group with Passive Content
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention Group with Active Content
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Technology Based Distractions
Intervention Description
Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)
Primary Outcome Measure Information:
Title
Change in Pain Score
Description
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.
Time Frame
Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Secondary Outcome Measure Information:
Title
Anxiety Score
Description
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.
Time Frame
Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Title
Anxiety Meter
Description
Childhood Anxiety Meter
Time Frame
Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Title
Family Satisfaction
Description
Family Satisfaction Survey
Time Frame
Immediately Post Non-Invasive Surgical Subspecialty Procedure
Title
Patient Satisfaction
Description
Patient Satisfaction Survey
Time Frame
Immediately Post Non-Invasive Surgical Subspecialty Procedure
Title
Patient Cooperation
Description
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.
Time Frame
At the time of Non-Invasive Surgical Subspecialty Procedure
Title
Patient Compliance
Description
Modified Induction Compliance Checklist
Time Frame
At the time of Non-Invasive Surgical Subspecialty Procedure
Title
Parent Pain Catastrophizing Scale (PCS-P)
Description
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.
Time Frame
Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Rodriguez, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

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