Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment
Condition: Autism Spectrum Disorder; Anesthesia; Procedural Anxiety; Sensory Processing Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The objective of this study is to prospectively examine the preoperative anxiety scores of
      ASD patients in an adaptive sensory environment. Additionally, the investigators aim to
      determine the relationship of severity of sensory integration in ASD patients and their
      preoperative anxiety scores. The study will also study the family satisfaction with tailored
      care of their ASD child in the peri-operative environment.
    

Detailed description: 
      At Dayton Children's, all patients with autism or other developmental delays are called prior
      to the day of surgery by child life specialists to obtain a coping plan to be entered into
      the EHR. Those patients that meet the criteria will be approached via telephone call 24-48
      hours prior to procedure by the research team to describe the study and gauge interest in
      participating.

      The pilot study will recruit a total of sixty patients in two parallel groups randomized to
      1:1 allocation: control group (standard practice with no sensory adaptive environment) or
      intervention group (sensory adaptive environment). Patients will be randomized in varying
      block sizes using a random number generator to ensure equal numbers in each group. The random
      allocation, block sizes, and block sequences will be concealed from study personnel and each
      patient until the time a patient is assigned to a group.

      In the preoperative area of main campus perioperative services there are three dedicated
      adaptive sensory friendly rooms for patients to await surgery. For the sensory adaptive
      environment, the room will be set up in accordance with the patient's coping plan and
      individual needs regarding sound, light, activity level, and other stimuli. The equipment may
      include a portable popcorn tube with fiberoptic cart, handheld marble panel, color changing
      floor tiles, other sensory friendly objects, and individual sensory toys.

      After registration and informed consent, the patient will be placed in either a standard
      preoperative room (control) or the dedicated sensory rooms (intervention) in the preoperative
      surgery area based on prior randomization. The patient's behaviors will be recorded by a
      research assistant at three time points (registration, nursing intake in preoperative room,
      and immediately prior to transition to operating room) by utilizing the validated modified
      Yale Preoperative Anxiety Scale (mYPAS). The mYPAS is the most widely used tool for assessing
      preoperative anxiety in children. The total score on the mYPAS will be the primary outcome
      for the study.

      In addition to the mYPAS measurements, the patient will be evaluated in the operating room
      utilizing the validated Child Induction Behavioral Assessment Scale (CIBA). The CIBA is a
      3-category behavioral assessment for documenting children's behavioral responses to induction
      of anesthesia. The 3 categories, Smooth, Moderate, and Difficult have associated behavioral
      descriptions that are scored at the time of anesthesia induction. The CIBA will be evaluated
      by the assigned anesthesia staff and documented in the EHR, as current standard practice.

      While the patient is in the procedure, families will fill out two questionnaires in the
      waiting room. The first is a 23-item questionnaire (Patient Experience Study Survey)
      regarding the patient preoperative experience.

      The second questionnaire is the Short Sensory Profile 2 (SSP-2), which assesses the patient's
      sensory processing abilities. The SSP-2 score will be used as a surrogate for the severity of
      sensory sensitivity in the study patient.

      In addition to the SSP-2, the following independent variables will be extracted from the
      medical record: patient demographics (sex, age, weight), ASA score designated by
      anesthesiologist, diagnosis and health history, procedure, home medications, preoperative
      medications including dose and route, intraoperative medications, event times and durations
      (including preoperative wait time, transport to OR time, induction to anesthesia ready, case
      length, & recovery time), and first recovery room pain score (documented by PACU RN via FLACC
      score).
    

Intervention name(s): Sensory adaptive environment
Intervention type(s): Other
Intervention description(s): A dedicated, private room that is set up in accordance with the patient's coping plan and individual needs regarding sound, light, activity level, and other stimuli.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The control group will be standard practice with no sensory adaptive environment and the intervention group with be a sensory adaptive environment. Patients will be randomized in varying block sizes using a random number generator to ensure equal numbers in each group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pediatric Anesthesia; Autism Spectrum Disorder; Procedural Anxiety