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NCT Number: NCT06324955

Language During Inhalational Induction

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.

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Key information

Conditions

Emergence Delirium Anesthesia; Adverse Effect Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard/common language during induction

Behavioral

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

Positive language during induction

Behavioral

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

Primary outcomes

  1. Induction compliance

    Time frame: 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 outcomes

  1. Length of induction

    Time frame: Through Study Completion about 1 day

    Time from start of induction to loss of lid reflex

  2. Verbal refusal of mask

    Time frame: Through Study Completion about 1 day

    Patient verbal expression of refusal of the mask during start of induction until loss of lid reflex

Study contacts

Contact information is provided by the study sponsor or research team.

John Fiadjoe, MD

CONTACT

[email protected]

617-355-7737

Rachel Bernier, MPH

CONTACT

[email protected]

857-218-5348

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 22, 2024
Registry last updated
Jan 9, 2026

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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