Trials / Completed
CompletedNCT00581139
Psychological Influences on Postoperative Recovery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- All
- Age
- 3 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Care, Postoperative
- Pain, Postoperative
- Surgical Procedures, Operative
- Otorhinolaryngologic Surgical Procedures
- Tonsillectomy
- Adenoidectomy
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Preoperative Preparation Program (Child Life Specialist) | This group will receive the standard preoperative visit to the hospital with Child Life intervention |
| DRUG | Midazolam | 0.5 mg/kg oral midazolam |
| BEHAVIORAL | Parental Presence during Induction of Anesthesia | One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program. |
| OTHER | PPIA preparation program PLUS Midazolam premedication | Subjects in this group will receive both interventions 2 and 3. |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2009-04-01
- Completion
- 2009-04-01
- First posted
- 2007-12-27
- Last updated
- 2023-09-07
- Results posted
- 2023-09-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00581139. Inclusion in this directory is not an endorsement.