Use of an Educational Story to Prepare Children With Developmental Disabilities for Sleep Study
Completed · Not applicable
Conditions studied: Developmental Disabilities, Sleep Disorders, Polysomnography, Preparation for Medical Procedure, Child
In brief
The investigators hypothesize that use of an educational story with pictures illustrating overnight sleep study procedure (also called polysomnography or PSG)accompanied by simple narrative will be a cost-effective, readily accepted intervention that will contribute to successful completion of sleep studies among children with disabilities. Children who have been referred for a clinical sleep study at Kennedy Krieger Institute (KKI) will be enrolled and randomized to either recieve usual care (discussion of polysomnography with referring clinicians) or educational story intervention. Both groups of participants will be asked to complete questionnaries before and after the sleep study. Set-up for the sleep study will be videotaped so that behavior of the child can be evaluated. The investigators will evaluate whether successful study completion differs between the two groups.
Key facts
- Study ID
- NCT02132273
- Run by
- Jennifer Accardo
- People needed
- 26
- Starts
- 2014-04-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-09-27
Who can join
Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical recommendation for polysomnography to be performed at KKI Clinical Neurophysiology Laboratory
- age 4 -17 years
- adequate health to tolerate procedure without additional nursing care
- English speaking caregiver, over 18 years of age
- Caregiver must have full guardianship of child participant
- Caregiver must be able to complete written questionnaires and read the educational story to their child
- Caregiver must be able to accompany child participant to the sleep study
You may not qualify if…
- non-english speaking children
- children in foster care or wards of the state
- child with absence of developmental disability
- child with presence of severe-profound intellectual disability
- child with severe disruptive or aggressive behaviors
- recommended for titration study (CPAP and/or supplemental oxygen)
- children requiring behavioral desensitization prior to sleep study.
- Caregivers that are non-English Speaking
- Caregivers that are under 18 years of age
- foster parents or temporary guardians
- cargivers with inability to reach educational story and/or complete questionnaires.
- caregiver is unable to accompany the child to the sleep study
Where it is running
- Kennedy Krieger Institute — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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