Language During Inhalational Induction

A Prospective Randomized Study Comparing Positive Language vs Common Language During Inhalational Induction

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06324955

Enrollment

128

Registered

2024-03-22

Start date

2024-04-08

Completion date

2027-04-30

Last updated

2026-01-09

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

Conditions

Anesthesia; Adverse Effect, Emergence Delirium

Keywords

Anesthesia induction

Brief summary

The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group.

Interventions

BEHAVIORALStandard/common language during induction

The anesthesiologist taking care of the patient will use scripted common/standard language during the induction.

BEHAVIORALPositive language during induction

The anesthesiologist taking care of the patient will use scripted positive language during the induction.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 10 Years

Healthy volunteers

Inclusion criteria

* ASA 1 and 2 (Healthy Patients) * Non-emergent cases * 5-10 year olds * Patients receiving inhalational induction

Exclusion criteria

* Non-English speaking * History of prior inhalational inductions * Hearing difficulty * Behavioral difficulty (Autism, Oppositional Defiant Disorder) * Patients receiving premedication other than midazolam

Design outcomes

Primary

Measure	Time frame	Description
Induction compliance	Through Study Completion about 1 day	Compliance of children during mask induction as measured by the Induction Compliance Checklist (ICC) from the time patient enters the operating room until loss of lid reflex

Secondary

Measure	Time frame	Description
Length of induction	Through Study Completion about 1 day	Time from start of induction to loss of lid reflex
Verbal refusal of mask	Through Study Completion about 1 day	Patient verbal expression of refusal of the mask during start of induction until loss of lid reflex

Countries

United States

Contacts

Primary ContactJohn Fiadjoe, MD

john.fiadjoe@childrens.harvard.edu617-355-7737

Backup ContactRachel Bernier, MPH

rachel.bernier@childrens.harvard.edu857-218-5348

Outcome results

None listed

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