Trial Outcomes & Findings for Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old (NCT NCT05368961)
NCT ID: NCT05368961
Last Updated: 2024-04-01
Results Overview
Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".
COMPLETED
NA
137 participants
Pre-induction of mask anesthesia in the operating room
2024-04-01
Participant Flow
Children ages 3-5 years were recruited from the pre-operative area at a single surgery site between April 2017 to March 2019.
Participant milestones
| Measure |
Usual Care
Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care
|
Distraction
Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet)
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
63
|
|
Overall Study
COMPLETED
|
47
|
52
|
|
Overall Study
NOT COMPLETED
|
27
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old
Baseline characteristics by cohort
| Measure |
Usual Care
n=47 Participants
Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care
|
Distraction
n=52 Participants
Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet)
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
47 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
3 years old
|
24 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Age, Customized
4 years old
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Age, Customized
5 years old
|
7 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Type of surgery
Ear Nose Throat
|
20 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Type of surgery
Ophthalmology
|
13 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Type of surgery
Urology
|
10 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Type of surgery
General Surgery
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Pre-induction of mask anesthesia in the operating roomPre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".
Outcome measures
| Measure |
Usual Care
n=47 Participants
Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care
|
Distraction
n=52 Participants
Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet)
|
|---|---|---|
|
mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"
|
20 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Pre-induction of mask anesthesia in the operating roomSedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".
Outcome measures
| Measure |
Usual Care
n=47 Participants
Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care
|
Distraction
n=52 Participants
Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet)
|
|---|---|---|
|
Sedation/Agitation
Sedated
|
1 Participants
|
0 Participants
|
|
Sedation/Agitation
Calm
|
42 Participants
|
45 Participants
|
|
Sedation/Agitation
Agitated
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: After surgery when patient woke up in the post anesthesia care unit (recovery room)Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool. The scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of "emergence delirium."
Outcome measures
| Measure |
Usual Care
n=47 Participants
Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care
|
Distraction
n=52 Participants
Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet)
|
|---|---|---|
|
Number of Participants Experiencing Emergence Delirium
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: After surgery at the time of admission to post anesthesia care unit (recovery room)Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".
Outcome measures
| Measure |
Usual Care
n=47 Participants
Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care
|
Distraction
n=52 Participants
Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet)
|
|---|---|---|
|
Sedation/Agitation
Sedated
|
45 Participants
|
48 Participants
|
|
Sedation/Agitation
Calm
|
0 Participants
|
3 Participants
|
|
Sedation/Agitation
Agitated
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Post operative until discharged from post anesthesia care unit (recovery room)Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit.
Outcome measures
| Measure |
Usual Care
n=47 Participants
Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care
|
Distraction
n=52 Participants
Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet)
|
|---|---|---|
|
Length of Stay (Minutes)
|
88.0 Minutes
Interval 78.0 to 101.0
|
75.5 Minutes
Interval 59.5 to 98.0
|
SECONDARY outcome
Timeframe: After surgery in the post anesthesia care unit from admission to dischargeThe number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged).
Outcome measures
| Measure |
Usual Care
n=47 Participants
Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care
|
Distraction
n=52 Participants
Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet)
|
|---|---|---|
|
The Number of Patients Experiencing Postoperative Vomiting
|
1 Participants
|
2 Participants
|
Adverse Events
Usual Care
Distraction
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michelle Levay, Nurse Research Manager
Cleveland Clinic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place