Trial Outcomes & Findings for REducing Anxiety in CHildren Undergoing Procedures (NCT NCT03054077)
NCT ID: NCT03054077
Last Updated: 2017-10-10
Results Overview
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.
COMPLETED
NA
24 participants
Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes
2017-10-10
Participant Flow
Participant milestones
| Measure |
Control or Group 1
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
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
REducing Anxiety in CHildren Undergoing Procedures
Baseline characteristics by cohort
| Measure |
Control or Group 1
n=12 Participants
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
n=12 Participants
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
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutesPopulation: All participants for whom 3 time points were collected at Baseline T1, T2, and T3
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.
Outcome measures
| Measure |
Control or Group 1
n=11 Participants
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
n=11 Participants
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
|
|---|---|---|
|
Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2
Time Point 1
|
25 units on a scale
Interval 19.81 to 30.15
|
29.69 units on a scale
Interval 18.73 to 40.65
|
|
Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2
Time Point 2
|
28.82 units on a scale
Interval 19.55 to 38.09
|
24.83 units on a scale
Interval 21.23 to 28.43
|
|
Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2
Time Point 3
|
34.09 units on a scale
Interval 13.19 to 54.99
|
26.56 units on a scale
Interval 15.75 to 37.37
|
Adverse Events
Control or Group 1
Intervention Group or Group 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place