Autism Spectrum DisorderNCT04994613
Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment
A study testing Sensory adaptive environment in people with Autism Spectrum Disorder and Anesthesia, run by Dayton Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Anesthesia, Procedural Anxiety
- What is being tested?
- Sensory adaptive environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- Sensory adaptive environment
- Keywords
- Pediatric Anesthesia, Autism Spectrum Disorder, Procedural Anxiety
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory adaptive environmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sensory adaptive environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Obtained during patient's procedure.
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.
Measured: Obtained during patient's procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start20 Sep 2021
- Primary completion12 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dayton Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Robert C. Cohn Research Endowment
- Responsible party
- Principal investigator, Sean Antosh, Dayton Children's Hospital
- Investigators
- Sean P Antosh, MD, Principal investigator, Dayton Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994613
- Sponsor's protocol ID
- 21-037
- Status last verified
- Dec 2023
- First submitted
- 3 Aug 2021
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29226493Arnold 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.
PubMed 26338278Taghizadeh 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.
PubMed 26248302Swartz 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.
PubMed 28618130Cermak 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.
PubMed 25931290Kain 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.
PubMed 9322455Winterberg 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.
PubMed 30531219Simpson 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.
PubMed 30673910Chojnicka 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.
PubMed 31689792Hanna 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.
PubMed 30328648Kerimoglu 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.
PubMed 24257388Lee 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.
PubMed 23011563Antosh 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.
PubMed 38645550
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment
- ClinicalTrials.gov ID
- NCT04994613
- Acronym / sponsor ID
- 21-037
- Keywords
- Pediatric Anesthesia, Autism Spectrum Disorder, Procedural Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dayton Children's HospitalUniversity, hospital or other
- Collaborators
- The Robert C. Cohn Research Endowment
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Sensory adaptive environmentOne 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory adaptive environmentA 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. | Other | Sensory Adaptive Environment Group |
Primary outcome
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.
2 secondary outcomes
Determine the relationship of severity of sensory integration in ASD patients and their preoperative anxiety scores.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Background: PubMed 29226493Elliott 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.
- Background: PubMed 26338278Arnold 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.
- Background: PubMed 26248302Taghizadeh 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.
- Background: PubMed 28618130Swartz 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.
- Background: PubMed 25931290Cermak 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.
- Background: PubMed 9322455Kain 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.
- Background: PubMed 30531219Winterberg 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.
- Background: PubMed 30673910Simpson 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.
- Background: PubMed 31689792Chojnicka 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.
- Background: PubMed 30328648Hanna 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.
- Background: PubMed 24257388Kerimoglu 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.
- Background: PubMed 23011563Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P Antosh, MD principal investigator
Dayton Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory adaptive environment in people with Autism Spectrum Disorder and Anesthesia, run by Dayton Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994613, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.