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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control or Group 1 | No Intervention | This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group. | |
| Intervention group or Group 2 | Experimental | This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPad with downloaded games | Other | iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | 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. | Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debbie Shockey, DNP | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24491647 | Background | Banchs RJ, Lerman J. Preoperative anxiety management, emergence delirium, and postoperative behavior. Anesthesiol Clin. 2014 Mar;32(1):1-23. doi: 10.1016/j.anclin.2013.10.011. | |
| 25010821 | Background | 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):643-650. doi: 10.1213/ANE.0000000000000350. |
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No anticipated sharing IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Control or Group 1 | This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group. |
| FG001 | Intervention Group or Group 2 | This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening. iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control or Group 1 | This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group. |
| BG001 | Intervention Group or Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | 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. | All participants for whom 3 time points were collected at Baseline T1, T2, and T3 | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes |
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control or Group 1 | This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Shockey | Virginia Commonwealth University | 804-828-3744 | dpshockey@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 14, 2017 | Aug 11, 2017 | Prot_SAP_ICF_000.pdf |
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RCT with a control arm equivalent to current standard of care and an intervention arm that includes standard of care plus the addition of an iPad with downloaded games.
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Blinding occurs through the randomization. Once the assignment to either group 1 (control) or group 2 (intervention) occurs all participants, care providers and investigators will be aware of which group is which.
| 9322455 | Background | 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. doi: 10.1097/00000539-199710000-00012. |
| 17197846 | Background | Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013. |
This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.
iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Control or Group 1 | This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group. |
| OG001 | Intervention Group or Group 2 | This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening. iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Intervention Group or Group 2 | This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening. iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit | 0 | 12 | 0 | 12 | 0 | 12 |
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