NCT01858142

Brief Summary

Children are distressed at anesthesia induction and this distress can result in maladaptive recovery outcomes. Having parents be present at anesthesia induction (PPIA) has been suggested as a potential intervention to decrease children's distress, and this intervention is widely favored by parents. However, to date, PPIA has not been found to be effective in reducing children's anxiety. The lack of efficacy may be attributable to the fact that parents have generally not been prepared for PPIA. The one study that prepared parents (as part of a larger preoperative preparation program) found that PPIA with preparation was superior to PPIA as previously studied (without preparation). Unfortunately, this program is resource intensive and therefore is not clinically feasible. This study will compare PPIA with a clinically feasible preparation program to PPIA with standard care (minimal preparation). Should our intervention show evidence of efficacy, the investigators will have designed a program that is easily translatable to everyday clinical practice. This will, in turn, reduce children's anxiety, improve postoperative outcomes and increase parental satisfaction.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 9, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

May 9, 2013

Last Update Submit

March 18, 2016

Conditions

Pre-operative Anxiety

Keywords

Pediatric anesthesiaPre-operative anxietyparental presencechildrenelective surgical proceduresmask induction

Outcome Measures

Primary Outcomes (1)

  • Modified Yale Pre-Operative Anxiety Scale

    Yale Preoperative Anxiety Scale (mYPAS; Kain et al., 1997). This researcher completed measure is made up of 5 categories (e.g., activity, vocalizations) each rated on ordinal behaviorally anchored scales. Total scores on the measure range from 23 to 100, with higher scores indicating higher child anxiety at induction. The tool has shown good convergent validity with another measure of child anxiety (r = 0.79), and excellent inter-rater reliability (kappa range 0.63-0.90). A cutoff score of 30 has been shown to have the best balance of sensitivity (0.85) and specificity (0.92). NOTE: Most of the measure is administered post-treatment, but part of it begins pre-treatment at baseline.

    post-treatment (following intervention); average=15 minutes after treatment

Study Arms (2)

Preparation intervention

EXPERIMENTAL

The parental presence decision tool will be delivered as an App shown to families using an iPAD and a set of headphones. This App will include information on what to expect in the operating room as well as the role of the parents. The App incorporates the basic principles of other effective perioperative preparation interventions (e.g., providing both sensory and procedural information) and is tailored to the local context. In addition to preparatory information, the App will also inform parents of the role of parent anxiety on children's outcomes in the operating room.

Behavioral: Parental presence decision tool

Standard preparation

PLACEBO COMPARATOR

In standard preparation condition, treating nurses and anesthesiologists will provide information to parents as they standardly do when parents are present at induction; this includes information on logistical issues and safety in the operating room (e.g., where to stand, how to put on gown) and risks of anesthesia induction. Additionally, parents in the standard preparation condition will view a summary of this standard information as text on an iPAD.

Behavioral: Standard preparation

Interventions

Parental presence decision toolBEHAVIORAL
Preparation intervention
Standard preparationBEHAVIORAL
Standard preparation

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 2 to 10
  • Scheduled for elective surgical procedure at IWK Health Centre
  • Mask induction
  • ASA classification I or II

You may not qualify if:

  • Intravenous induction
  • Diagnosed development delay
  • ASA classification III or higher
  • Pre-medication with benzodiazepine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Interventions

Reference Standards

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

Study Officials

  • Jill Chorney, PhD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 21, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

CA(1)