Anxiety Clinical Trial
— ACTOfficial title:
Adaptive Care in the Perioperative Setting: An Observational Study
NCT number | NCT03353129 |
Other study ID # | 2017-0758 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 15, 2017 |
Est. completion date | February 28, 2018 |
Verified date | August 2019 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The overall purpose for conducting this research is to improve the safety and efficacy of care for perioperative patients who have developmental delays and behavioral challenges. The specific objectives for this study are to describe distress behaviors and interventions used in the ACT population. The investigators will also determine the relationship between a predictive measure of distress (the Psychosocial Risk Assessment in Pediatrics score) with the actual distress behaviors exhibited by patients in the perioperative area. This study will provide knowledge that is necessary in order to develop best practices and to guide future research for this patient population. Further understanding the techniques used to improve care in the perioperative setting may also provide useful information to consider in other healthcare settings where this patient population has difficulty with coping and cooperating (ex. vaccinations, placing IVs, dental work, etc.).
Status | Completed |
Enrollment | 60 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 21 Years |
Eligibility |
Inclusion Criteria: - Patients who meet the following criteria for the ACT Program: - Patient is diagnosed with a developmental disability and/or behavioral condition - Patient has demonstrated inability to cope and cooperate during a healthcare encounter without additional preparation and support - Patient scores greater than 7 on the PRAP scale - Patient has 1 or more of the commonly seen ACT patient diagnoses listed in the diagnoses list below (additional diagnoses may be added the discretion of the principal investigator) - Patients accompanied to the appointment by parents or legal guardian - Patients of any gender, race, and ethnicity are potentially eligible for inclusion - Patients who are scheduled as outpatients or for 23 hour observation - Patient is ambulatory (able to walk and can use all 4 extremities for activities of daily living) Diagnoses list: - Autism Spectrum Disorder, Autism, Autistic - Delay in Development, Unspecified delay in development, Developmental Delay, Unspecified intellectual disability - Down's Syndrome, Trisomy 21 - Other developmental speech or language disorder - Other specific developmental learning difficulties - Problems in communication - Mental and behavioral problems - ADD/ADHD - Impulse control disorder - Anxiety disorder - Disruptive behavior disorder - Intermittent explosive disorder - Obsessive Compulsive Disorder - Oppositional defiant disorder - Sensory Integration Disorder - Pervasive Development Disorder - Receptive Expressive Language Disorder Exclusion Criteria: - Guardian unable to provide consent - Wheel chair bound - Prior enrollment in this research study - Patients who are scheduled to be admitted (greater than 23 hours) and inpatients - Patients who do not meet the ACT criteria - Any patient who, in the judgment of the investigators, has insufficient data to complete analysis - Adult patients (age 18-21) who have cognitive delays but are their own legal guardian |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Balakas K, Gallaher CS, Tilley C. Optimizing perioperative care for children and adolescents with challenging behaviors. MCN Am J Matern Child Nurs. 2015 May-Jun;40(3):153-9. doi: 10.1097/NMC.0000000000000124. — View Citation
Beringer RM, Segar P, Pearson A, Greamspet M, Kilpatrick N. Observational study of perioperative behavior changes in children having teeth extracted under general anesthesia. Paediatr Anaesth. 2014 May;24(5):499-504. doi: 10.1111/pan.12362. Epub 2014 Feb 3. — View Citation
Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-50. doi: 10.1213/ANE.0000000000000350. — View Citation
Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-54, table of contents. — View Citation
Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. — 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. — View Citation
Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. — View Citation
Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998 Nov;89(5):1147-56; discussion 9A-10A. — View Citation
Karam VY, Barakat H. Perioperative management of the child with behavioral disorders. Middle East J Anaesthesiol. 2011 Jun;21(2):191-7. Review. — View Citation
McCann ME, Kain ZN. The management of preoperative anxiety in children: an update. Anesth Analg. 2001 Jul;93(1):98-105. Review. — View Citation
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. — View Citation
Staab JH, Klayman GJ, Lin L. Assessing pediatric patient's risk of distress during health-care encounters: The psychometric properties of the Psychosocial Risk Assessment in Pediatrics. J Child Health Care. 2014 Dec;18(4):378-87. doi: 10.1177/1367493513496671. Epub 2013 Aug 12. — View Citation
Thompson DG, Tielsch-Goddard A. Improving management of patients with autism spectrum disorder having scheduled surgery: optimizing practice. J Pediatr Health Care. 2014 Sep-Oct;28(5):394-403. doi: 10.1016/j.pedhc.2013.09.007. Epub 2013 Nov 25. — View Citation
Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008 Aug;107(2):413-21. doi: 10.1213/ane.0b013e31817e616b. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distress behaviors and interventions used in Adaptive Care Team program | Best practices to foundationalize and guide future research for this patient population | 6-9 months | |
Primary | Expansion of Best Practices to other Healthcare Settings | Implementation of Best Practices in other healthcare settings where this patient population has difficulty with coping and cooperating (ex. vaccinations, placing IVs, dental work, etc.). | 6-9 months |
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