Emergence DeliriumNCT06324955
Language During Inhalational Induction
A study testing Standard/common language during induction and Positive language during induction in people with Emergence Delirium and Anesthesia; Adverse Effect, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Emergence Delirium, Anesthesia; Adverse Effect
- What is being tested?
- Standard/common language during induction and Positive language during induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA 1 and 2 (Healthy Patients)
- Non-emergent cases
- 5-10 year olds
- Patients receiving inhalational induction
Who cannot join
- Non-English speaking
- History of prior inhalational inductions
- Hearing difficulty
- Behavioral difficulty (Autism, Oppositional Defiant Disorder)
- Patients receiving premedication other than midazolam
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Julia Galvez-Delgado, MD, julia.galvezdelgado@childrens.harvard.edu
Rachel Bernier, MPH, 857-218-5348, rachel.bernier@childrens.harvard.edu
About this study
Official title: 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.
- Conditions
- Emergence Delirium, Anesthesia; Adverse Effect
- Being tested
- Standard/common language during induction, Positive language during induction
- Keywords
- Anesthesia induction
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard/common language during inductionBehavioural
The anesthesiologist taking care of the patient will use scripted common/standard language during the induction.
Positive language during inductionBehavioural
The anesthesiologist taking care of the patient will use scripted positive language during the induction.
| Study group | Role | What they receive |
|---|---|---|
| Common/Standard Language Group | Active comparator | Not described Receives: Behavioral: Standard/common language during induction |
| Positive Language Group | Experimental | Not described Receives: Behavioral: Positive language during induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through Study Completion about 1 day
Secondary outcomes (2)
Length of induction
Time from start of induction to loss of lid reflex
Measured: Through Study Completion about 1 day
Verbal refusal of mask
Patient verbal expression of refusal of the mask during start of induction until loss of lid reflex
Measured: Through Study Completion about 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start8 Apr 2024
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Galvez-Delgado, Boston Children's Hospital
- Investigators
- John Fiadjoe, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324955
- Sponsor's protocol ID
- IRB-P00042507
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing Positive Language vs Common Language During Inhalational Induction
- ClinicalTrials.gov ID
- NCT06324955
- Acronym / sponsor ID
- IRB-P00042507
- Conditions
- Emergence Delirium, Anesthesia; Adverse Effect
- Keywords
- Anesthesia induction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common/Standard Language Group | Active comparator | Behavioral: Standard/common language during induction |
| Positive Language Group | Experimental | Behavioral: Positive language during induction |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA 1 and 2 (Healthy Patients)
- Non-emergent cases
- 5-10 year olds
- Patients receiving inhalational induction
Key exclusion criteria (5 listed)
- Non-English speaking
- History of prior inhalational inductions
- Hearing difficulty
- Behavioral difficulty (Autism, Oppositional Defiant Disorder)
- Patients receiving premedication other than midazolam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard/common language during inductionThe anesthesiologist taking care of the patient will use scripted common/standard language during the induction. | Behavioural | Common/Standard Language Group |
| Positive language during inductionThe anesthesiologist taking care of the patient will use scripted positive language during the induction. | Behavioural | Positive Language Group |
Primary outcome
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
2 secondary outcomes
Length of induction
Time frame: Through Study Completion about 1 day
Verbal refusal of mask
Time frame: Through Study Completion about 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Fiadjoe, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard/common language during induction and Positive language during induction in people with Emergence Delirium and Anesthesia; Adverse Effect, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Fiadjoe, MD (617-355-7737, john.fiadjoe@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction compliance (time frame: Through Study Completion about 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.