Psychological Influences on Postoperative Recovery

Study Overview
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Brief Summary
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The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.

Official Title
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Psychological Influences on Postoperative Recovery

Conditions
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Care, Postoperative, Pain, Postoperative, Surgical Procedures, Operative, Otorhinolaryngologic Surgical Procedures, Tonsillectomy, Adenoidectomy

Intervention / Treatment
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* Behavioral: Preoperative Preparation Program (Child Life Specialist)
* Drug: Midazolam
* Behavioral: Parental Presence during Induction of Anesthesia
* Other: PPIA preparation program PLUS Midazolam premedication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Behavioral: Preoperative Preparation Program (Child Life Specialist)<br>* This group will receive the standard preoperative visit to the hospital with Child Life intervention<br>|
| Active Comparator: 2<br> | Drug: Midazolam<br>* 0.5 mg/kg oral midazolam<br>* Other names: Versed;|
| Active Comparator: 3<br> | Behavioral: Parental Presence during Induction of Anesthesia<br>* 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.<br>* Other names: PPIA Preparation Program;|
| Active Comparator: 4<br> | Other: PPIA preparation program PLUS Midazolam premedication<br>* Subjects in this group will receive both interventions 2 and 3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |