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

IWK Health Centre

Status: Completed

Conditions: Pre-operative Anxiety

Treatments: Behavioral: Standard preparation; Behavioral: Parental presence decision tool

Study type: Interventional

Funder types: Other

Identifiers

NCT01858142

1012940

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups, including a placebo group

Preparation intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Parental presence decision tool

Standard preparation

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Standard preparation