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

Primary Purpose

Autism Spectrum Disorder, Anesthesia, Procedural Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensory adaptive environment
Sponsored by
Dayton Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Pediatric Anesthesia, Autism Spectrum Disorder, Procedural Anxiety

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dayton Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Sensory Adaptive Environment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Examine the preoperative anxiety scores of ASD patients in an adaptive sensory environment.
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.
2. Determine the relationship of severity of sensory integration in ASD patients and their preoperative anxiety scores.
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. 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.
3. Explore family satisfaction with tailored care of their ASD child in the peri-operative environment.
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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2021
Last Updated
August 30, 2023
Sponsor
Dayton Children's Hospital
Collaborators
The Robert C. Cohn Research Endowment
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1. Study Identification

Unique Protocol Identification Number
NCT04994613
Brief Title
Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment
Official Title
Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dayton Children's Hospital
Collaborators
The Robert C. Cohn Research Endowment

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Anesthesia, Procedural Anxiety, Sensory Processing Disorder
Keywords
Pediatric Anesthesia, Autism Spectrum Disorder, Procedural Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Sensory Adaptive Environment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sensory adaptive environment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Examine the preoperative anxiety scores of ASD patients in an adaptive sensory environment.
Description
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.
Time Frame
From procedural registration to induction of anesthesia (approximately 1-2 hours)
Title
2. Determine the relationship of severity of sensory integration in ASD patients and their preoperative anxiety scores.
Description
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. 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.
Time Frame
Obtained during patient's procedural time.
Title
3. Explore family satisfaction with tailored care of their ASD child in the peri-operative environment.
Description
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.
Time Frame
Obtained during patient's procedural time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Formal diagnosis of Autism Spectrum Disorder, Asperger's Syndrome, or pervasive developmental disorder NOS Presenting for outpatient surgery at Dayton Children's Hospital main campus Exclusion Criteria: A coping plan is not able to be obtained prior to day of surgery An American Society of Anesthesiology (ASA) risk score greater than 3 Non-English speaking Refusal of participation by guardian
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean P Antosh, MD
Organizational Affiliation
Dayton Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29226493
Citation
Elliott AB, Holley AL, Ross AC, Soleta AO, Koh JL. A prospective study comparing perioperative anxiety and posthospital behavior in children with autism spectrum disorder vs typically developing children undergoing outpatient surgery. Paediatr Anaesth. 2018 Feb;28(2):142-148. doi: 10.1111/pan.13298. Epub 2017 Dec 10.
Results Reference
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Citation
Arnold B, Elliott A, Laohamroonvorapongse D, Hanna J, Norvell D, Koh J. Autistic children and anesthesia: is their perioperative experience different? Paediatr Anaesth. 2015 Nov;25(11):1103-10. doi: 10.1111/pan.12739. Epub 2015 Sep 4.
Results Reference
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PubMed Identifier
26248302
Citation
Taghizadeh N, Davidson A, Williams K, Story D. Autism spectrum disorder (ASD) and its perioperative management. Paediatr Anaesth. 2015 Nov;25(11):1076-84. doi: 10.1111/pan.12732. Epub 2015 Aug 6.
Results Reference
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PubMed Identifier
28618130
Citation
Swartz JS, Amos KE, Brindas M, Girling LG, Ruth Graham M. Benefits of an individualized perioperative plan for children with autism spectrum disorder. Paediatr Anaesth. 2017 Aug;27(8):856-862. doi: 10.1111/pan.13189. Epub 2017 Jun 15.
Results Reference
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Cermak SA, Stein Duker LI, Williams ME, Dawson ME, Lane CJ, Polido JC. Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study. J Autism Dev Disord. 2015 Sep;45(9):2876-88. doi: 10.1007/s10803-015-2450-5.
Results Reference
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PubMed Identifier
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Citation
Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
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Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment

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