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NCT01878747 · ClinicalTrials.gov registry record · NA
Healthcare Provider Behavior and Children's Perioperative Distress
A NA study of Pain, Postoperative and Infant Behavior, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 1,471
- Enrollment target
- 6
- Study locations
NCT01878747: Completed NA study of Pain, Postoperative and Infant Behavior, sponsored by University of California, Irvine.
NCT01878747 is a NA study of Pain, Postoperative and Infant Behavior that has completed, run by University of California, Irvine. The registered enrollment target is 1,471 participants, above the 260-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (466% higher). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01878747, a NA study of Pain, Postoperative and Infant Behavior, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,471 participants
- Enrollment target
- 6
- Study locations
Study Summary
The goal of this randomized trial is to examine the effectiveness of a Provider Tailored Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly developed intervention, or a Control Group who will receive a 2-hour seminar on the management of preoperative anxiety and postoperative pain and otherwise will provide standard care. The aims of this study are to: PRIMARY AIM 1\. Determine if P-TIPS is more effective than standard care for preventing high preoperative anxiety among children undergoing anesthesia and surgery. The primary outcome will be observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale Preoperative Anxiety Scale). SECONDARY AIMS 1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain, recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral changes as measured by the PAED, and PHBQ 2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires 3. Determine if HCP in P-TIPS group display more desired behaviors and less undesired behaviors as compared to control group and whether these behaviors mediate the child and parent-level outcomes.These behaviors will be measured using the m-PCAMPIS
Primary Outcome
m-YPAS (modified-Yale Preoperative Anxiety Scale)
Conditions Studied
Interventions
- BEHAVIORAL Provider Tailored Intervention for Perioperative Stress
Study Locations (6)
California
- Children's Hospital Los Angeles - Los Angeles
- Stanford University - Menlo Park
- CHOC Children's Hospital - Orange
Colorado
- Children's Hospital Colorado - Aurora
Georgia
- Boyd Graduate Studies Research Center - Athens
Nova Scotia
- IWK Health Center - Halifax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,471 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT01878747 record still lists
NCT01878747 is an interventional study that assigns participants to a tested intervention. Its 1,471 participants enrollment target places it among the larger protocols in the corpus, above the 260-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (466% higher).
The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 1 intervention - of which Provider Tailored Intervention for Perioperative Stress is the first listed.
NCT01878747 lists 6 locations in 4 states (California, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT01878747 about?
NCT01878747 is a clinical study titled "Healthcare Provider Behavior and Children's Perioperative Distress". The goal of this randomized trial is to examine the effectiveness of a Provider Tailored Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers (HCP) in it will be random...
What is the current status of trial NCT01878747?
This trial is currently completed. It is a NA study. The enrollment target is 1,471 participants. The study started on 2011-06. Estimated completion is 2016-06.
What conditions does trial NCT01878747 study?
This clinical trial studies the following conditions: Pain, Postoperative, Infant Behavior.
What interventions are being tested in trial NCT01878747?
The interventions under investigation include: Provider Tailored Intervention for Perioperative Stress (BEHAVIORAL).
Who is sponsoring clinical trial NCT01878747?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01878747 being conducted?
This trial has 6 study locations across California, Colorado, Georgia, Nova Scotia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01878747's enrollment target sits among peer trials
1,471 3rd of 113 higher than 111 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
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