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Psychological Influences on Postoperative Recovery (NIH)

Primary Purpose

Care, Postoperative, Pain, Postoperative, Surgical Procedures, Operative

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Preoperative Preparation Program (Child Life Specialist)
Midazolam
Parental Presence during Induction of Anesthesia
PPIA preparation program PLUS Midazolam premedication
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Care, Postoperative

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Outpatient tonsillectomy or tonsils/adenoids
  • ASA I, II

Exclusion Criteria:

  • Developmental delay
  • ASA III-IV
  • Psychotropic medication
  • Meds which interfere with metabolism of midazolam
  • 36 weeks gestation

Sites / Locations

  • Yale University Department of Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

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.
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
Percent of Children Crying During Induction
Children who were crying/ had tears in their eyes during induction.
Percentage of Children Arriving to PACU Awake
Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake
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
Post Anesthesia Care Unit (PACU) IV Fluid
Total IV fluid per kg in PACU
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.
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

Secondary Outcome Measures

Full Information

First Posted
December 18, 2007
Last Updated
August 25, 2023
Sponsor
University of California, Irvine
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00581139
Brief Title
Psychological Influences on Postoperative Recovery
Acronym
NIH
Official Title
Psychological Influences on Postoperative Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Care, Postoperative, Pain, Postoperative, Surgical Procedures, Operative, Otorhinolaryngologic Surgical Procedures, Tonsillectomy, Adenoidectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Preoperative Preparation Program (Child Life Specialist)
Intervention Description
This group will receive the standard preoperative visit to the hospital with Child Life intervention
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
0.5 mg/kg oral midazolam
Intervention Type
Behavioral
Intervention Name(s)
Parental Presence during Induction of Anesthesia
Other Intervention Name(s)
PPIA Preparation Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PPIA preparation program PLUS Midazolam premedication
Intervention Description
Subjects in this group will receive both interventions 2 and 3.
Primary Outcome Measure Information:
Title
Modified Yale Preoperative Anxiety Scale
Description
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.
Time Frame
Day of surgery
Title
Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)
Description
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
Time Frame
Induction, up to 10 minutes
Title
Percent of Children Crying During Induction
Description
Children who were crying/ had tears in their eyes during induction.
Time Frame
Induction, up to 10 minutes
Title
Percentage of Children Arriving to PACU Awake
Description
Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake
Time Frame
Arrival at PACU, after surgery up to 20 minutes
Title
Percentage of Children Arriving to PACU in Deep Sleep
Description
Whether child arrived to PACU awake Emergence of 2 // whether child arrived to PACU in deep sleep
Time Frame
Arrival at PACU, after surgery up to 20 minutes
Title
Post Anesthesia Care Unit (PACU) IV Fluid
Description
Total IV fluid per kg in PACU
Time Frame
Post Anesthesia Care Unit up to 2 hours
Title
Visual Analogue Pain Scale (VAS) 24 Hour After Surgery
Description
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.
Time Frame
24 Hours after surgery
Title
Heart Rate in the General Clinical Research Unit (GCRC)
Description
Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery
Time Frame
Hour 0-6 after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatient tonsillectomy or tonsils/adenoids ASA I, II Exclusion Criteria: Developmental delay ASA III-IV Psychotropic medication Meds which interfere with metabolism of midazolam 36 weeks gestation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeev N Kain, MD, MBA
Organizational Affiliation
Yale University Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University Department of Anesthesiology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Psychological Influences on Postoperative Recovery

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