Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment

December 21, 2023 updated by: Sean Antosh, Dayton Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Dayton, Ohio, United States, 45305
        • Dayton Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Formal diagnosis of Autism Spectrum Disorder, Asperger's Syndrome, or pervasive developmental disorder NOS
  2. Presenting for outpatient surgery at Dayton Children's Hospital main campus

Exclusion Criteria:

  1. A coping plan is not able to be obtained prior to day of surgery
  2. An American Society of Anesthesiology (ASA) risk score greater than 3
  3. Non-English speaking
  4. Refusal of participation by guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The patient will be reserved a standard room in the preoperative area of main campus. This room will not include any additional sensory equipment. The child will be allowed to use any comfort items the family brought with them or offered a hospital iPad, as is current practice for all outpatient surgery patients.
Experimental: Sensory Adaptive Environment Group
One of the three dedicated adaptive sensory rooms in the preoperative area of main campus will be set up by nursing and child life staff 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. This room will be set up prior to the patient's arrival the day of surgery and reserved for their use.
Other: Sensory adaptive environment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine the preoperative anxiety scores of ASD patients in an adaptive sensory environment.
Time Frame: From procedural registration to induction of anesthesia (approximately 1-2 hours)
The validated modified Yale Preoperative Anxiety Scale (mYPAS) will be utilized to assess anxiety and behaviors at three time points in the preoperative process, to include registration in the surgery lobby, preoperative nurse intake in the individual room, and immediately prior to transition to operating room.mYPAS consists of 5 items; 4 of the items (Activity, Emotional Expressivity, State of Apparent Arousal, and Use of Parent) are rated on scales of 1-4, and 1 item (Vocalizations) is rated on a scale of 1-6. The total score is determined by dividing each item rating by its highest possible rating, summing the results, dividing by 5, and then multiplying by 100. Total scores can range from 23.33 to 100, with higher scores representing greater anxiety.
From procedural registration to induction of anesthesia (approximately 1-2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the relationship of severity of sensory integration in ASD patients and their preoperative anxiety scores.
Time Frame: Obtained during patient's procedure.
Patient's primary caregiver will complete 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. The SSP-2 consists of 34 behavioral items measured on 5-point Likert scales from 1 = almost never to 5 = almost always. Items are divided into 4 quadrants for scoring, Seeking (7 items), Avoiding (9 items), Sensitivity (10 items), and Registration (8 items) based on Dunn's Sensory Processing Framework. Two subscale scores, Sensory Processing and Behavioral Responses Associated with Sensory Processing, as well as total scores are also determined. Raw scores are compared to a normal curve and Sensory Profile 2 Classification System developed from a normative sample.
Obtained during patient's procedure.
Explore family satisfaction with tailored care of their ASD child in the peri-operative environment.
Time Frame: Obtained during patient's procedure.
Patient's primary caregiver will document on a 23-item questionnaire (Patient Experience Study Survey) regarding the patient preoperative experience. The first section includes yes/no questions regarding parent's discussions with Dayton Children's Child Life prior to the day of surgery in developing the coping plan. The second and third sections use positively worded statements measured on 5-point Likert scales from 1 = strongly disagree to 5 = strongly agree. These two sections discuss the preoperative holding room and environment on the day of surgery (9 items), and how the perioperative team related to the patient (5 items). Total scores across all items will be determined, as well as scores within each of the 3 sections. A final item will ask the family to rate the overall experience on a 10-point scale from 1 = very dissatisfied to 10 = very satisfied.
Obtained during patient's procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dayton Children's Hospital

Collaborators

The Robert C. Cohn Research Endowment

Investigators

  • Principal Investigator: Sean P Antosh, MD, Dayton Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Actual)

May 12, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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