Anxiety Clinical Trial
Official title:
Adaptive Care in the Perioperative Setting: An Observational Study
The overall purpose for conducting this research is to improve the safety and efficacy of care for perioperative patients who have developmental delays and behavioral challenges. The specific objectives for this study are to describe distress behaviors and interventions used in the ACT population. The investigators will also determine the relationship between a predictive measure of distress (the Psychosocial Risk Assessment in Pediatrics score) with the actual distress behaviors exhibited by patients in the perioperative area. This study will provide knowledge that is necessary in order to develop best practices and to guide future research for this patient population. Further understanding the techniques used to improve care in the perioperative setting may also provide useful information to consider in other healthcare settings where this patient population has difficulty with coping and cooperating (ex. vaccinations, placing IVs, dental work, etc.).
For this study the investigators will measure anxiety and distress behaviors using multiple
validated scales, including the modified Yale Pre-operative Anxiety Score (m-YPAS), the
Induction Compliance Checklist (ICC), the Child Induction Behavioral Assessment (CIBA) tool
and the Post-Anesthesia Emergence Delirium scale (PAED). Each of these scales is
observational (as opposed to self-report), so they can be used in young patients who are
not-yet verbal or for developmentally delayed children. Other than the PRAP, the scales were
not originally developed for patients who have developmental delays (our team is not aware of
perioperative behavioral scales that are validated for this population specifically). The
scales are reliable with young, minimally verbal children, so the investigators anticipate
that the scales will provide adequate measures. The investigators plan to document any
challenges in using the scales so that future researchers may consider improving the scales
for this population, if indicated.
In addition to understanding distress behaviors, gaining an understanding of what
interventions are being used to decrease a patient's risk for having distress is also
important. There is limited research describing the use of medication and behavioral
interventions for the ACT population. Multiple articles describe behavioral interventions
that are recommended, but there is little data on what interventions are being used in
clinical practice for high-risk patients. There is also little direct evidence published on
the use of oral anxiety medications for children in the ACT population undergoing surgery. In
2011, Cincinnati Children's Hospital Medical Center published a BESt Evidence Statement on
the use of anxiolytic medications prior to ambulatory healthcare encounters for individuals
with special developmental and behavioral challenges. The statement recommends the use of
certain pre-procedural anxiolytic medications when non-pharmacological support interventions
have been unsuccessful or when the patient has been assessed as having very high anxiety
using a distress assessment tool or clinical judgment. Our anesthesia team has anecdotally
found these medication guidelines to be very useful in clinical practice. The investigators
have not yet studied the use of these medications in our hospital, however, and dissemination
of the practice statement in other settings has been limited. Further evidence of how these
guidelines are used is necessary to support their efficacy and to make recommendations for
updating the BESt Evidence statement.
In addition to the medications outlined in the BESt Evidence Statement (clonazepam,
risperidone, and lorazepam) there are a number of other medications that can contribute to
preoperative anxiolysis including midazolam, diazepam, dexmedetomidine, clonidine, olanzapine
and ketamine. There are case reports and retrospective data on the use of these medications
in patients who would fit the ACT patient criteria, but our team has not come across any
prospective study data that describes the use of these medications for high risk patients in
clinical practice. This study will provide much needed data to give a better understanding of
perioperative experiences and interventions used for ACT patients. This information could
facilitate the development of better defined best practices and help to determine areas for
further research.
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