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NCT00581139 · ClinicalTrials.gov registry record · Phase 2
Psychological Influences on Postoperative Recovery
A Phase 2 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 2
- Development phase
- 241
- Enrollment target
NCT00581139: Completed Phase 2 study, sponsored by University of California, Irvine.
NCT00581139 is a Phase 2 study that has completed, run by University of California, Irvine. The registered enrollment target is 241 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00581139, a Phase 2 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 241 participants
- Enrollment target
Study Summary
The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.
Primary Outcome
The Modified Yale Preoperative Anxiety Scale (mYPAS) is the current "criterion standard" for assessing child anxiety during induction of anesthesia and has been used in \>100 studies. This observational instrument covers 5 items and is typically administered at 4 perioperative time points. Minimum value is 23.33 and maximum value is 100. Scores below 30 are considered low anxiety. Score of 30 or more is considered high anxiety.
Interventions
- DRUG Midazolam
- BEHAVIORAL Preoperative Preparation Program (Child Life Specialist)
- BEHAVIORAL Parental Presence during Induction of Anesthesia
- OTHER PPIA preparation program PLUS Midazolam premedication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2003-04 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00581139 record still lists
NCT00581139 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% higher).
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT00581139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00581139 about?
NCT00581139 is a clinical study titled "Psychological Influences on Postoperative Recovery". The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.
What is the current status of trial NCT00581139?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 241 participants. The study started on 2003-04. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00581139?
The interventions under investigation include: Midazolam (DRUG), Preoperative Preparation Program (Child Life Specialist) (BEHAVIORAL), Parental Presence during Induction of Anesthesia (BEHAVIORAL), PPIA preparation program PLUS Midazolam premedication (OTHER).
Who is sponsoring clinical trial NCT00581139?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00581139's enrollment target sits among peer trials
241 239th of 2000 higher than 1,762 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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