Helping Parents to Decide Whether They Want to be With Their Child During Anesthesia Induction

Not Applicable

Completed

• Conditions: Pre-operative Anxiety
• Interventions: Behavioral: Standard preparation; Behavioral: Parental presence decision tool

• Registration Number: NCT01858142
• Lead Sponsor: IWK Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-21
• Study Start: 2013-06
• Primary Completion: 2013-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard preparation	Standard preparation	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.
Preparation intervention	Parental presence decision tool	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.

Primary Outcome Measures

Name	Time	Method
Modified Yale Pre-Operative Anxiety Scale	post-treatment (following intervention); average=15 minutes after treatment	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.

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada