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

NCT04994613 | Completed

• 1 other identifier: 21-037
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Anesthesia; Procedural Anxiety; Sensory Processing Disorder

Keywords

Pediatric Anesthesia; Autism Spectrum Disorder; Procedural Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  From procedural registration to induction of anesthesia (approximately 1-2 hours)

Secondary Outcomes (2)

• Determine the relationship of severity of sensory integration in ASD patients and their preoperative anxiety scores.

  Obtained during patient's procedure.

• Explore family satisfaction with tailored care of their ASD child in the peri-operative environment.

  Obtained during patient's procedure.

Study Arms (2)

Control Group

NO INTERVENTION

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.

Sensory Adaptive Environment Group

EXPERIMENTAL

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

Interventions

Sensory adaptive environment OTHER

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.

Sensory Adaptive Environment Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dayton Children's Hospital: lead
• The Robert C. Cohn Research Endowment: collaborator

Study Sites (1)

Dayton Children's Hospital

Dayton, Ohio, 45305, United States

Location

Related Publications (13)

• 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.

  PMID: 29226493 BACKGROUND

• 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.

  PMID: 26338278 BACKGROUND

• 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.

  PMID: 26248302 BACKGROUND

• 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.

  PMID: 28618130 BACKGROUND

• 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.

  PMID: 25931290 BACKGROUND

• 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.

  PMID: 9322455 BACKGROUND

• Winterberg AV, Ding L, Hill LM, Stubbeman BL, Varughese AM. Validation of a Simple Tool for Electronic Documentation of Behavioral Responses to Anesthesia Induction. Anesth Analg. 2020 Feb;130(2):472-479. doi: 10.1213/ANE.0000000000003945.

  PMID: 30531219 BACKGROUND

• Simpson K, Adams D, Alston-Knox C, Heussler HS, Keen D. Exploring the Sensory Profiles of Children on the Autism Spectrum Using the Short Sensory Profile-2 (SSP-2). J Autism Dev Disord. 2019 May;49(5):2069-2079. doi: 10.1007/s10803-019-03889-2.

  PMID: 30673910 BACKGROUND

• Chojnicka I, Pisula E. Adaptation and psychometric properties of the Polish version of the Short Sensory Profile 2. Medicine (Baltimore). 2019 Nov;98(44):e17689. doi: 10.1097/MD.0000000000017689.

  PMID: 31689792 BACKGROUND

• Hanna AH, Ramsingh D, Sullivan-Lewis W, Cano S, Leiter P, Wallace D, Andrews G, Austin B, Applegate RL 2nd. A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double-blinded clinical trial. Paediatr Anaesth. 2018 Dec;28(12):1109-1115. doi: 10.1111/pan.13501. Epub 2018 Oct 17.

  PMID: 30328648 BACKGROUND

• Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.

  PMID: 24257388 BACKGROUND

• Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.

  PMID: 23011563 BACKGROUND

• Antosh S, Drennan C, Stolfi A, Lawson R, Huntley E, McCullough-Roach R, Hill M, Adelekan T, Vachhrajani S. Use of an adaptive sensory environment in patients with autism spectrum disorder (ASD) in the perioperative environment: a parallel, randomized controlled trial. Lancet Reg Health Am. 2024 Apr 18;33:100736. doi: 10.1016/j.lana.2024.100736. eCollection 2024 May.

  PMID: 38645550 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sean P Antosh, MD

  Dayton Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthesiologist

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 6, 2021
• Study Start: September 20, 2021
• Primary Completion: May 12, 2022
• Study Completion: June 1, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)