Language During Inhalational Induction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA 1 and 2 (Healthy Patients)
Non-emergent cases
5-10 year olds
Patients receiving inhalational induction
Disqualifiers
Non-English speaking
History of prior inhalational inductions
Hearing difficulty
Behavioral difficulty (Autism, Oppositional Defiant Disorder)
Trial design
Design model
Parallel
Treatments tested in this trial
Standard/common language during induction
BehavioralThe anesthesiologist taking care of the patient will use scripted common/standard language during the induction.
Positive language during induction
BehavioralThe anesthesiologist taking care of the patient will use scripted positive language during the induction.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Common/Standard Language GroupActive comparator 1 intervention
Group B: Positive Language GroupExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Through Study Completion about 1 daySecondary outcomes
1
Length of induction
Time from start of induction to loss of lid reflex
Time frame
Through Study Completion about 1 day2
Verbal refusal of mask
Patient verbal expression of refusal of the mask during start of induction until loss of lid reflex
Time frame
Through Study Completion about 1 daySponsors and contacts
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Source ClinicalTrials.gov