| Registry | NCT04994613 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, supportive care |
| Enrollment | 60 (Actual) |
| Sponsor | Dayton Children's Hospital (Other); collaborators: The Robert C. Cohn Research Endowment |
| Conditions | Autism Spectrum Disorder, Anesthesia, Procedural Anxiety, Sensory Processing Disorder |
| Interventions | Sensory adaptive environment (Other) |
| Dates | start 2021-09-20, primary completion 2022-05-12, completion 2022-06-01, first posted 2021-08-06, last updated 2023-12-28 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Autism Spectrum Disorder All trials for Anesthesia All trials of Sensory adaptive environment
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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 environment | 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. |
Sex: All, ages: 3 Years to 12 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Dayton Children's Hospital | Dayton, Ohio | United States |