Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT06324955

Conditions

Emergence Delirium

Anesthesia; Adverse Effect

Eligibility Criteria

Sex: All

Age: 5 - 10

Healthy Volunteers: Not accepted

Interventions

Standard/common language during induction

Positive language during induction

Study Details

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.

Conditions

Emergence Delirium

Anesthesia; Adverse Effect

Study ID

NCT06324955

Start date

Apr 8, 2024

Status verified date

Dec, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 10

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Common/Standard Language Group

experimental: Positive Language Group

Interventions

Standard/common language during induction

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

Positive language during induction

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

Primary outcome measure

  • Induction compliance [ Time Frame: Through Study Completion about 1 day ]

Central Contacts and Locations

Central contacts

John Fiadjoe, MD

617-355-7737john.fiadjoe@childrens.harvard.edu

Rachel Bernier, MPH

857-218-5348rachel.bernier@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Julia Galvez-Delgado, MD

julia.galvezdelgado@childrens.harvard.edu

Rachel Bernier, MPH

857-218-5348rachel.bernier@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jan 9, 2026

Last verified

Dec, 2025

Keywords

  • Anesthesia induction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-01-09.