Trial Outcomes & Findings for Relationship Between Preoperative Anxiety, Postoperative Pain, and Emergence Delirium in Pediatric Surgery (NCT NCT07343388)
NCT ID: NCT07343388
Last Updated: 2026-04-24
Results Overview
Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. This behavioral scale assesses pain in children who cannot communicate verbally. Each of the five categories is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate increased pain intensity (0: Relaxed/Comfortable, 1-3: Mild discomfort, 4-6: Moderate pain, 7-10: Severe pain/discomfort).
COMPLETED
114 participants
Postoperatively at 0, 15, 30, 45, and 60 minutes.
2026-04-24
Participant Flow
Participant milestones
| Measure |
High Anxiety Group (mYPAS ≥ 30)
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of 30 or higher
|
Low Anxiety Group (mYPAS < 30)
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of less than 30.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
64
|
|
Overall Study
COMPLETED
|
50
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Anxiety Group (mYPAS ≥ 30)
n=50 Participants
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of 30 or higher
|
Low Anxiety Group (mYPAS < 30)
n=64 Participants
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of less than 30.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.04 Years
STANDARD_DEVIATION 1.71 • n=50 Participants
|
4.41 Years
STANDARD_DEVIATION 1.92 • n=64 Participants
|
4.68 Years
STANDARD_DEVIATION 1.85 • n=114 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=50 Participants
|
4 Participants
n=64 Participants
|
10 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=50 Participants
|
60 Participants
n=64 Participants
|
104 Participants
n=114 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Postoperatively at 0, 15, 30, 45, and 60 minutes.Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. This behavioral scale assesses pain in children who cannot communicate verbally. Each of the five categories is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate increased pain intensity (0: Relaxed/Comfortable, 1-3: Mild discomfort, 4-6: Moderate pain, 7-10: Severe pain/discomfort).
Outcome measures
| Measure |
High Anxiety Group (mYPAS ≥ 30)
n=50 Participants
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of 30 or higher
|
Low Anxiety Group (mYPAS < 30)
n=64 Participants
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of less than 30.
|
|---|---|---|
|
Postoperative Pain Intensity
0. minute
|
1 score
Interval 0.0 to 5.0
|
1 score
Interval 0.0 to 3.0
|
|
Postoperative Pain Intensity
15. minute
|
3 score
Interval 0.2 to 5.0
|
1 score
Interval 0.0 to 3.2
|
|
Postoperative Pain Intensity
30. minute
|
0 score
Interval 0.0 to 2.8
|
0 score
Interval 0.0 to 2.0
|
|
Postoperative Pain Intensity
45. minute
|
0 score
Interval 0.0 to 2.0
|
0.5 score
Interval 0.0 to 3.0
|
|
Postoperative Pain Intensity
60. minute
|
1 score
Interval 0.0 to 2.0
|
0 score
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Postoperatively at 0, 15, 30, 45, and 60 minutes.Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale consists of five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability. The total score ranges from 0 to 20, where higher scores indicate greater severity of delirium. A score of 10 or higher is considered clinically significant for the presence of emergence delirium.
Outcome measures
| Measure |
High Anxiety Group (mYPAS ≥ 30)
n=50 Participants
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of 30 or higher
|
Low Anxiety Group (mYPAS < 30)
n=64 Participants
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of less than 30.
|
|---|---|---|
|
Incidence and Severity of Emergence Delirium
0. minute
|
12 score
Interval 8.2 to 12.0
|
10 score
Interval 6.0 to 12.0
|
|
Incidence and Severity of Emergence Delirium
15. minute
|
7 score
Interval 5.0 to 9.8
|
5.5 score
Interval 1.8 to 7.2
|
|
Incidence and Severity of Emergence Delirium
30. minute
|
3.5 score
Interval 0.0 to 6.0
|
0 score
Interval 0.0 to 3.0
|
|
Incidence and Severity of Emergence Delirium
45. minute
|
2 score
Interval 0.0 to 5.0
|
0 score
Interval 0.0 to 3.0
|
|
Incidence and Severity of Emergence Delirium
60. minute
|
2 score
Interval 0.2 to 4.0
|
0 score
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Postoperatively at 0, 15, 30, 45, and 60 minutes.Measured using the Modified Aldrete Score, which evaluates five criteria: activity, respiration, circulation, consciousness, and oxygen saturation. Each criterion is scored 0, 1, or 2. The total score ranges from 0 to 10. Higher scores indicate better physical recovery and greater readiness for discharge from the Post-Anesthesia Care Unit (PACU). A score of 9 or 10 is typically required for safe discharge.
Outcome measures
| Measure |
High Anxiety Group (mYPAS ≥ 30)
n=50 Participants
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of 30 or higher
|
Low Anxiety Group (mYPAS < 30)
n=64 Participants
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of less than 30.
|
|---|---|---|
|
Postoperative Physical Recovery and Discharge Readiness
0. minute
|
8 score
Interval 8.0 to 9.0
|
8 score
Interval 8.0 to 9.0
|
|
Postoperative Physical Recovery and Discharge Readiness
15. minute
|
10 score
Interval 9.0 to 10.0
|
10 score
Interval 9.0 to 10.0
|
|
Postoperative Physical Recovery and Discharge Readiness
30. minute
|
10 score
Interval 10.0 to 10.0
|
10 score
Interval 10.0 to 10.0
|
|
Postoperative Physical Recovery and Discharge Readiness
45. minute
|
10 score
Interval 10.0 to 10.0
|
10 score
Interval 10.0 to 10.0
|
|
Postoperative Physical Recovery and Discharge Readiness
60. minute
|
10 score
Interval 10.0 to 10.0
|
10 score
Interval 10.0 to 10.0
|
Adverse Events
High Anxiety Group (mYPAS ≥ 30)
Low Anxiety Group (mYPAS < 30)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gonul Sari
University of Health Sciences, Dr. Behcet Uz Children's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place