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Completed

NCT Number: NCT01858142

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

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.

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Key information

Conditions

Pre-operative Anxiety

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parental presence decision tool

Behavioral

Standard preparation

Behavioral

Primary outcomes

  1. Modified Yale Pre-Operative Anxiety Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

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

Acronym: PPDT

Important dates

Study start
2013
Primary completion
2013
First posted
May 21, 2013
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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