Psychological Influences on Postoperative Recovery
NIH
2 other identifiers
interventional
241
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 18, 2007
CompletedFirst Posted
Study publicly available on registry
December 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
September 7, 2023
CompletedSeptember 7, 2023
August 1, 2023
6 years
December 18, 2007
June 3, 2021
August 25, 2023
Conditions
Outcome Measures
Primary Outcomes (8)
Modified Yale Preoperative Anxiety Scale
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.
Day of surgery
Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)
A total score is the number of categories checked (1-10). A perfect induction is when a patient does not exhibit negative behaviors, fear, or anxiety. A perfect score would be 0. icc 1 = Crying, tears in eyes icc 2 = Turns head away from mask icc 3 = Verbal refusal, says "no" icc 4 = Verbalization indicating fear or worry, "Where's mommy?" or "Will it hurt?" icc 5 = Pushes mask away with hands, pushes nurse/anesthesiologist with hands/feet icc 6 = Covers mouth/nose with hands/arms or buries face icc 7 = Hysterical crying, may scream icc8 = Kicks/flails legs/arms, arches back, and/or general struggling icc9 = Requires physical restraint icc10 = Complete passivity either rigid or limp icc 0 = Perfect induction
Induction, up to 10 minutes
Percent of Children Crying During Induction
Children who were crying/ had tears in their eyes during induction.
Induction, up to 10 minutes
Percentage of Children Arriving to PACU Awake
Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake
Arrival at PACU, after surgery up to 20 minutes
Percentage of Children Arriving to PACU in Deep Sleep
Whether child arrived to PACU awake Emergence of 2 // whether child arrived to PACU in deep sleep
Arrival at PACU, after surgery up to 20 minutes
Post Anesthesia Care Unit (PACU) IV Fluid
Total IV fluid per kg in PACU
Post Anesthesia Care Unit up to 2 hours
Visual Analogue Pain Scale (VAS) 24 Hour After Surgery
Parent-ranted child pain on the Visual Analogue Scale. The VAS for pain is a unidimensional measure of pain presented in a horizontal line from 0-100. A higher score indicates greater pain intensity. 0-4= no pain/anxiety, 5-44= mild pain/anxiety, 45-74 = moderate pain/anxiety, 75-100 = severe pain/anxiety.
24 Hours after surgery
Heart Rate in the General Clinical Research Unit (GCRC)
Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery
Hour 0-6 after surgery
Study Arms (4)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATOR3
ACTIVE COMPARATOR4
ACTIVE COMPARATORInterventions
This group will receive the standard preoperative visit to the hospital with Child Life intervention
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.
Subjects in this group will receive both interventions 2 and 3.
Eligibility Criteria
You may qualify if:
- Outpatient tonsillectomy or tonsils/adenoids
- ASA I, II
You may not qualify if:
- Developmental delay
- ASA III-IV
- Psychotropic medication
- Meds which interfere with metabolism of midazolam
- weeks gestation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale University Department of Anesthesiology
New Haven, Connecticut, 06510, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Zeev Kain
- Organization
- University of California, Irvine
Study Officials
- PRINCIPAL INVESTIGATOR
Zeev N Kain, MD, MBA
Yale University Department of Anesthesiology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 18, 2007
First Posted
December 27, 2007
Study Start
April 1, 2003
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
September 7, 2023
Results First Posted
September 7, 2023
Record last verified: 2023-08