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

NCT ID: NCT01858142

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30

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.

Conditions

Pre-operative Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Preparation intervention

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.

Group Type: EXPERIMENTAL

Parental presence decision tool

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

Standard preparation

Intervention Type: BEHAVIORAL

Interventions

Parental presence decision tool

Intervention Type: BEHAVIORAL

Standard preparation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Patrick J. McGrath

Supervisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Chorney, PhD

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

IWK Health Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

1012940

Identifier Type: -

Identifier Source: org_study_id