Language During Inhalational Induction
A Prospective Randomized Study Comparing Positive Language vs Common Language During Inhalational Induction
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedStudy Start
First participant enrolled
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
January 9, 2026
December 1, 2025
2.9 years
March 8, 2024
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Induction compliance
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
Through Study Completion about 1 day
Secondary Outcomes (2)
Length of induction
Through Study Completion about 1 day
Verbal refusal of mask
Through Study Completion about 1 day
Study Arms (2)
Common/Standard Language Group
ACTIVE COMPARATORPositive Language Group
EXPERIMENTALInterventions
The anesthesiologist taking care of the patient will use scripted common/standard language during the induction.
The anesthesiologist taking care of the patient will use scripted positive language during the induction.
Eligibility Criteria
You may qualify if:
- ASA 1 and 2 (Healthy Patients)
- Non-emergent cases
- year olds
- Patients receiving inhalational induction
You may not qualify if:
- Non-English speaking
- History of prior inhalational inductions
- Hearing difficulty
- Behavioral difficulty (Autism, Oppositional Defiant Disorder)
- Patients receiving premedication other than midazolam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Fiadjoe, MD
Boston Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
March 8, 2024
First Posted
March 22, 2024
Study Start
April 8, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
January 9, 2026
Record last verified: 2025-12