Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04994613
Other study ID # 21-037
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2021
Est. completion date June 1, 2022

Study information

Verified date December 2023
Source Dayton Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 1, 2022
Est. primary completion date May 12, 2022
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Dayton Children's Hospital Dayton Ohio

Sponsors (2)

Lead Sponsor Collaborator
Dayton Children's Hospital The Robert C. Cohn Research Endowment

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Determine the relationship of severity of sensory integration in ASD patients and their preoperative anxiety scores. 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.
Secondary 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. Obtained during patient's procedure.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas