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Sensory adaptive environment for Autism Spectrum Disorder
N/A
Waitlist Available
Led By Sean P Antosh, MD
Research Sponsored by Dayton Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up obtained during patient's procedure.
Awards & highlights
Study Summary
This study is evaluating whether ASD patients have higher anxiety scores in an adaptive sensory environment.
Eligible Conditions
- Autism Spectrum Disorder
- Autism
- Anesthesia
- Procedural Anxiety
- Sensory Processing Disorder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from procedural registration to induction of anesthesia (approximately 1-2 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from procedural registration to induction of anesthesia (approximately 1-2 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Examine the preoperative anxiety scores of ASD patients in an adaptive sensory environment.
Secondary outcome measures
Determine the relationship of severity of sensory integration in ASD patients and their preoperative anxiety scores.
Explore family satisfaction with tailored care of their ASD child in the peri-operative environment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sensory Adaptive Environment GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupActive Control1 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.
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Who is running the clinical trial?
The Robert C. Cohn Research EndowmentUNKNOWN
Dayton Children's HospitalLead Sponsor
12 Previous Clinical Trials
5,028,469 Total Patients Enrolled
Robert C. Cohn Memorial Research GrantUNKNOWN
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