Care, PostoperativePhase 2NIHNCT00581139
Psychological Influences on Postoperative Recovery
A Phase 2 study testing Preoperative Preparation Program (Child Life Specialist), Midazolam and Parental Presence during Induction of Anesthesia in people with Care, Postoperative and Pain, Postoperative, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Care, Postoperative, Pain, Postoperative, Surgical Procedures, Operative
- What is being tested?
- Preoperative Preparation Program (Child Life Specialist), Midazolam and Parental Presence during Induction of Anesthesia
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Outpatient tonsillectomy or tonsils/adenoids
- ASA I, II
Who cannot join
- Developmental delay
- ASA III-IV
- Psychotropic medication
- Meds which interfere with metabolism of midazolam
- 36 weeks gestation
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Department of Anesthesiology
New Haven, Connecticut, 06510
About this study
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
- Being tested
- Preoperative Preparation Program (Child Life Specialist), Midazolam, Parental Presence during Induction of Anesthesia, PPIA preparation program PLUS Midazolam premedication
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Preparation Program (Child Life Specialist)Behavioural
This group will receive the standard preoperative visit to the hospital with Child Life intervention
MidazolamDrug
Also called Versed
0.5 mg/kg oral midazolam
Parental Presence during Induction of AnesthesiaBehavioural
Also called PPIA Preparation Program
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.
PPIA preparation program PLUS Midazolam premedicationOther
Subjects in this group will receive both interventions 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: Preoperative Preparation Program (Child Life Specialist) |
| 2 | Active comparator | Not described Receives: Drug: Midazolam |
| 3 | Active comparator | Not described Receives: Behavioral: Parental Presence during Induction of Anesthesia |
| 4 | Active comparator | Not described Receives: Other: PPIA preparation program PLUS Midazolam premedication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Induction, up to 10 minutes
Percent of Children Crying During Induction
Children who were crying/ had tears in their eyes during induction.
Measured: 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
Measured: 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
Measured: Arrival at PACU, after surgery up to 20 minutes
Post Anesthesia Care Unit (PACU) IV Fluid
Total IV fluid per kg in PACU
Measured: 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.
Measured: 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
Measured: Hour 0-6 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startApr 2003
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Care, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Zeev Kain, University of California, Irvine
- Investigators
- Zeev N Kain, MD, MBA, Principal investigator, Yale University Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581139
- Sponsor's protocol ID
- 9801009972 [2008-6723]
- Other IDs
- R01HD037007-01
- Acronym
- NIH
- Status last verified
- Aug 2023
- First submitted
- 18 Dec 2007
- Last updated
- 7 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Influences on Postoperative Recovery
- ClinicalTrials.gov ID
- NCT00581139
- Acronym / sponsor ID
- NIH / 9801009972 [2008-6723]
- Conditions
- Care, Postoperative, Pain, Postoperative, Surgical Procedures, Operative, Otorhinolaryngologic Surgical Procedures, Tonsillectomy, Adenoidectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2003
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 7 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Preoperative Preparation Program (Child Life Specialist) |
| 2 | Active comparator | Drug: Midazolam |
| 3 | Active comparator | Behavioral: Parental Presence during Induction of Anesthesia |
| 4 | Active comparator | Other: PPIA preparation program PLUS Midazolam premedication |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Outpatient tonsillectomy or tonsils/adenoids
- ASA I, II
Key exclusion criteria (5 listed)
- Developmental delay
- ASA III-IV
- Psychotropic medication
- Meds which interfere with metabolism of midazolam
- 36 weeks gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Preparation Program (Child Life Specialist)This group will receive the standard preoperative visit to the hospital with Child Life intervention | Behavioural | 1 |
| MidazolamAlso: Versed0.5 mg/kg oral midazolam | Drug | 2 |
| Parental Presence during Induction of AnesthesiaAlso: PPIA Preparation ProgramOne 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. | Behavioural | 3 |
| PPIA preparation program PLUS Midazolam premedicationSubjects in this group will receive both interventions 2 and 3. | Other | 4 |
Primary outcome
Modified Yale Preoperative Anxiety Scale
Time frame: Day of surgery
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)
Time frame: Induction, up to 10 minutes
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
Time frame: Induction, up to 10 minutes
Children who were crying/ had tears in their eyes during induction.
Percentage of Children Arriving to PACU Awake
Time frame: Arrival at PACU, after surgery up to 20 minutes
Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake
Percentage of Children Arriving to PACU in Deep Sleep
Time frame: Arrival at PACU, after surgery up to 20 minutes
Whether child arrived to PACU awake Emergence of 2 // whether child arrived to PACU in deep sleep
Post Anesthesia Care Unit (PACU) IV Fluid
Time frame: Post Anesthesia Care Unit up to 2 hours
Total IV fluid per kg in PACU
Visual Analogue Pain Scale (VAS) 24 Hour After Surgery
Time frame: 24 Hours 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)
Time frame: Hour 0-6 after surgery
Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeev N Kain, MD, MBA principal investigator
Yale University Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preoperative Preparation Program (Child Life Specialist), Midazolam and Parental Presence during Induction of Anesthesia in people with Care, Postoperative and Pain, Postoperative, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Yale Preoperative Anxiety Scale (time frame: Day of surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.