Virginia Commonwealth University Health System
Richmond, Virginia, 23298, United States
NCT Number: NCT03054077
This is a small pilot, feasibility study designed as a quality improvement project. The purpose is to identify anxiety in children aged 4-12 years who will receive a sedated procedure and to see if the use of an iPad as a focused activity will decrease the level of anxiety through a small randomized control trial in the Children's Perioperative Unit.
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Notify Me4 year–12 year
All sexes
Interventional
Not applicable
Richmond, Virginia, 23298, United States
Description: The study is a quality improvement project and designed as a small pilot randomized control trial. Participants will be randomly assigned to either Group 1 (no intervention) or Group 2 (iPad intervention) via a number generator.
Children randomized to Group 1 receive the standard of care with observation and scoring of the mYPAS-SF occurring at three time points (T1 pre-operative holding area-patient room which is private, T2 induction of anesthesia, T3 awakening from sedation post procedure).
Children randomized to Group 2 will be observed at the same time points (T1, T2, T3) but will additionally interact with an iPad that has a selection of 3 games downloaded (3 games for children ages 4-7 and 3 games for children ages 8-12). The iPad is introduced in between T1 and T2 and then resumed at T3 until discharge from the clinical unit.
Process: Following IRB approval, the steps of the study are:
T2-Child observed prior to the induction of anesthesia (observation occurs just prior to the administration of anesthesia).
T3-Child observed upon return to private holding area and awakening from anesthesia (observation occurs when child awakens from the anesthesia).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit
Time frame: Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes
The Modified Yale Preoperative Anxiety Scale- Short form (mYPAS-SF) Ratings produce 4 mYPAS scores (1 for each time point)
Areas scored:
Activity (1,2,3, or 4) Vocalizations (1,2,3,4,5,or 6) Emotional Expressivity (1,2,3, or 4) State of Apparent arousal (1,2,3, or 4) Scoring: Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100.
This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety.
Comparison of scores between Group 1 and Group 2 to see if changes in anxiety scores occurred with the addition of the iPad.
All data will be gathered with review at the close of the study which is anticipated to occur in 5/20/2017.
Virginia Commonwealth University
Other
Acronym: REACH-UP!
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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