Trial Outcomes & Findings for Psychological Influences on Postoperative Recovery (NCT NCT00581139)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

241 participants

Primary outcome timeframe

Day of surgery

Results posted on

2023-09-07

Participant Flow

Recruitment occurred between 2003 and 2009 at the Yale Children's Hospital.

All enrolled participants were assigned to one of the four groups.

Participant milestones

Participant milestones
Measure	Standard of Care Preoperative Preparation Program (Child Life Specialist) : This group will receive the standard preoperative visit to the hospital with Child Life intervention	Pre-medication Midazolam : 0.5 mg/kg oral midazolam	Parental Presence During Induction of Anesthesia Parental Presence during Induction of Anesthesia : 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.	Parental Presence During Induction of Anesthesia PLUS Premedic PPIA preparation program PLUS Midazolam premedication : Subjects in this group will receive both interventions 2 and 3.
Overall Study STARTED	61	68	54	58
Overall Study COMPLETED	61	68	54	58
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Psychological Influences on Postoperative Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=57 Participants Preoperative Preparation Program (Child Life Specialist) : This group will receive the standard preoperative visit to the hospital with Child Life intervention	Pre-medication n=66 Participants Midazolam : 0.5 mg/kg oral midazolam	Parental Presence During Induction of Anesthesia n=54 Participants Parental Presence during Induction of Anesthesia : 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.	Parental Presence During Induction of Anesthesia PLUS Premedic n=56 Participants PPIA preparation program PLUS Midazolam premedication : Subjects in this group will receive both interventions 2 and 3.	Total n=233 Participants Total of all reporting groups
Age, Continuous	6.59 Years STANDARD_DEVIATION 2.578 • n=5 Participants	7.56 Years STANDARD_DEVIATION 6.48 • n=7 Participants	6.57 Years STANDARD_DEVIATION 2.57 • n=5 Participants	6.74 Years STANDARD_DEVIATION 2.50 • n=4 Participants	6.96 Years STANDARD_DEVIATION 4.14 • n=21 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	38 Participants n=7 Participants	31 Participants n=5 Participants	33 Participants n=4 Participants	127 Participants n=21 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	28 Participants n=7 Participants	23 Participants n=5 Participants	23 Participants n=4 Participants	106 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard of Care n=56 Participants Preoperative Preparation Program (Child Life Specialist) : This group will receive the standard preoperative visit to the hospital with Child Life intervention	Pre-medication n=60 Participants Midazolam : 0.5 mg/kg oral midazolam	Parental Presence During Induction of Anesthesia n=54 Participants Parental Presence during Induction of Anesthesia : 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.	Parental Presence During Induction of Anesthesia PLUS Premedic n=55 Participants PPIA preparation program PLUS Midazolam premedication : Subjects in this group will receive both interventions 2 and 3.
Modified Yale Preoperative Anxiety Scale	41.59 Score on mYPAS scale Standard Deviation 22.18	37.44 Score on mYPAS scale Standard Deviation 21.80	46.17 Score on mYPAS scale Standard Deviation 24.10	33.65 Score on mYPAS scale Standard Deviation 15.23

PRIMARY outcome

Timeframe: Induction, up to 10 minutes

Population: The discrepancy noted in the analysis population is due to missing data.

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