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

Pre-operative Anxiety Clinical Trial

— PPDT  

Official title:

Preparing Parents to be Present for Their Child's Anesthesia Induction: A Randomized Control Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858142
• Other study ID #: 1012940
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: April 16, 2014
• Start date: June 2013

Study information

• Verified date: April 2014
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-operative Anxiety

Intervention

Behavioral:
• Parental presence decision tool

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No