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Recruiting NCT06324955

Language During Inhalational Induction

No phase Interventional Emergence Delirium Anesthesia; Adverse Effect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard/common language during induction, Positive language during induction.
Who it may be relevant to
Registry conditions: Emergence Delirium, Anesthesia; Adverse Effect. Basic parameters: 5 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Standard/common language during induction
    The anesthesiologist taking care of the patient will use scripted common/standard language during the induction.
  • Behavioral Positive language during induction
    The anesthesiologist taking care of the patient will use scripted positive language during the induction.

Primary outcome measures

  • Induction compliance [Time frame: Through Study Completion about 1 day]
Secondary outcome measures (2)
  • Length of induction [Time frame: Through Study Completion about 1 day]
  • Verbal refusal of mask [Time frame: Through Study Completion about 1 day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

Identifiers

NCT: NCT06324955 · IRB-P00042507

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗