Clinical trial NCT03464955: VR Usage in Non-Invasive Surgical Sub-Specialty Procedures
Official title: Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Emotional
Stress, Psychological
Behavioral Symptoms
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 291
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Score
timeFrame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Secondary outcomes:
measure: Anxiety Score
timeFrame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
measure: Anxiety Meter
timeFrame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
measure: Family Satisfaction
timeFrame: Immediately Post Non-Invasive Surgical Subspecialty Procedure
measure: Patient Satisfaction
timeFrame: Immediately Post Non-Invasive Surgical Subspecialty Procedure
measure: Patient Cooperation
timeFrame: At the time of Non-Invasive Surgical Subspecialty Procedure
measure: Patient Compliance
timeFrame: At the time of Non-Invasive Surgical Subspecialty Procedure
measure: Parent Pain Catastrophizing Scale (PCS-P)
timeFrame: Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Samuel Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: