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Completed

NCT Number: NCT03464955

VR 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.

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Key information

Conditions

Stress, Emotional Behavior Behavioral Symptoms Stress, Psychological

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technology Based Distractions

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Anxiety Meter

    Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline

    Childhood Anxiety Meter

  3. Family Satisfaction

    Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure

    Family Satisfaction Survey

  4. Patient Satisfaction

    Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure

    Patient Satisfaction Survey

  5. 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.

  6. Patient Compliance

    Time frame: At the time of Non-Invasive Surgical Subspecialty Procedure

    Modified Induction Compliance Checklist

  7. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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