Language During Inhalational Induction

March 15, 2024 updated by: John Fiadjoe, Boston Children's Hospital

A Prospective Randomized Study Comparing Positive Language vs Common 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Common/Standard Language Group
Behavioral: Standard/common language during induction
The anesthesiologist taking care of the patient will use scripted common/standard language during the induction.
Experimental: Positive Language Group
Behavioral: Positive language during induction
The anesthesiologist taking care of the patient will use scripted positive language during the induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through Study Completion about 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of induction
Time Frame: Through Study Completion about 1 day
Time from start of induction to loss of lid reflex
Through Study Completion about 1 day
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
Through Study Completion about 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: John Fiadjoe, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 11, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

March 11, 2025

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00042507

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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