VR Usage in Non-Invasive Surgical Sub-Specialty Procedures
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 2 - 18 |
| Updated: | 4/17/2018 |
| Start Date: | October 16, 2017 |
| End Date: | October 16, 2019 |
| Contact: | Samuel Rodriguez, MD |
| Email: | sr1@stanford.edu |
| Phone: | 650-723-5728 |
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.
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.
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.
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.
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
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Sam Rodriguez, MD
Phone: 650-723-5728
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