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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01858142
Acronym
PPDT
Enrollment
104
Registered
2013-05-21
Start date
2013-06-30
Completion date
Unknown
Last updated
2016-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-operative Anxiety

Keywords

Pediatric anesthesia, Pre-operative anxiety, parental presence, children, elective surgical procedures, mask induction

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.

Interventions

BEHAVIORALParental presence decision tool

Sponsors

IWK Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Yale Pre-Operative Anxiety Scalepost-treatment (following intervention); average=15 minutes after treatmentYale 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026