AnxietyNCT07230743

The Study Evaluates the Effect of an Interactive Projector as a Distraction for Children During Anesthetic Induction. The Primary Objective is to Reduce Perioperative Anxiety, Measured With the Modified Yale Preoperative Anxiety Scale (mYPAS).

A study testing Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA) and Standard Parent-Present Induction (PPI) in people with Anxiety and Anxiety After Surgery, run by Clinica Alemana de Santiago at 1 site in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 2 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety, Anxiety After Surgery, Induction of Anesthesia
What is being tested?: Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA) and Standard Parent-Present Induction (PPI)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChile
Study dates: 1 Jul 2025to Jul 2026
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 2 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Patients undergoing elective procedures under general anesthesia at Clinica Alemana
Parent or caregiver presence for mask induction
ASA I, II
Ages 2-6 years of age
Spanish speaking
Parental consent/patient assent

Who cannot join

Patient or parental does not consent
ASA ≥ III
Emergency surgery
Intravenous induction of anesthesia
Patient with a significant neurological condition or major developmental disability
Severe visual or auditory defects
Patients admitted using a crib as the mode of transport

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ximena Mora Diez, MD contact

+569 95377637

xmora@alemana.cl

Rodrigo Guiloff Krauss, MD contact

56 222101111 ext. 6223

rguilofk@udd.cl

Chile1 site, 1 recruiting

Clínica Alemana de Santiago
Vitacura, Santiago Metropolitan, 7630000
Ximena Mora Diez, MD, +56995377637, ximenamora@udd.cl
Recruiting

Other trials in Chile

About this study

Official title: Comparison of Anxiety During Mask Induction of Anesthesia in Pediatric Patients With an Immersive/Interactive Technological Intervention Versus Traditional Care: A Latin American Experience

This study is designed to evaluate the effect of technology as a distraction technique during anesthetic induction in children, starting from their arrival to the operating room. An interactive film will be displayed using a projector (BERT: Bedside Entertaining and Relaxation Tool) mounted on a whiteboard in front of the child's gurney. The primary outcome is perioperative anxiety, measured with the Modified Yale Preoperative Anxiety Scale (mYPAS).

Read the detailed description

This study is a randomized, controlled, open-label, parallel-assignment clinical trial designed to evaluate the effect of a non-pharmacologic technological intervention (projected video game) on perioperative anxiety in children during anesthetic induction.

Study type: Prospective, comparative clinical trial. Randomization: Simple randomization in a 1:1 ratio using an electronic sequence generated and administered in REDCap®.

Masking: Open-label (no blinding), as healthcare staff, caregivers, and patients can identify the presence or absence of the projected video game during induction. However, statistical analyses will be performed by investigators who did not take part in the intervention's implementation, in order to minimize bias.

Conditions: Anxiety, Anxiety After Surgery, Induction of Anesthesia, Anxiety Preoperative, Anesthesia Care, Technology Use
Being tested: Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA), Standard Parent-Present Induction (PPI)
Keywords: Custom Projector-based Software Game, Pediatric Mask Induction Anxiety
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA)Device
Also called BERT
The interactive audiovisual content is displayed on a large projection screen strategically placed at the foot of the operating table to ensure optimal visibility for the pediatric patient. Children will be instructed to watch and engage with the content as they enter the operating room and throughout the induction process.
The intervention is designed to promote engagement and reduce perioperative anxiety. Research assistants will set up and operate the projection system and ensure appropriate timing and delivery. Caregivers and OR personnel will be permitted to interact with the child as usual during induction. The video intervention concludes upon loss of consciousness, at which point standard perioperative care resumes.
Standard Parent-Present Induction (PPI)Other
Participants in the Standard PPI group will undergo routine mask induction of anesthesia accompanied by a parent, with no additional structured distraction.

Study groups in NCT07230743
Study group	Role	What they receive
Standard Parent-Present Induction (PPI)	Active comparator	Participants in the Standard PPI group will undergo routine mask induction of anesthesia accompanied by a parent, with no additional structured distraction. Receives: Other: Standard Parent-Present Induction (PPI)
Technology Intervention group	Experimental	Participants in the Technology Intervention group will receive the same parent-present induction, with the addition of a custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA). The interactive audiovisual content is displayed on a large projection screen strategically placed at the foot of the operating table to ensure optimal visibility for the pediatric patient. Children will be instructed to watch and engage with the content as they enter the operating room and throughout the induction process. Receives: Device: Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA); Other: Standard Parent-Present Induction (PPI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Pediatric anxiety
Pediatric anxiety levels during mask induction as measured through the Modified Yale Preoperative Anxiety Scale (mYPAS). The Modified Yale Preoperative Anxiety Scale (mYPAS) is a 22-item checklist divided into five categories: "activity," "vocalization," "emotional expressiveness," "apparent arousal," and "relationship with parents." Each category consists of a list of interrelated behaviors, the most representative of which is the score for that category. The mYPAS score ranges from 23.3 to 100; the threshold for considering patients with anxiety is > 30.
Measured: Perioperative/anesthetic induction

Secondary outcomes (6)

Affect and Cooperation
To measure patient affect and cooperation during mask induction, measured by HRAD +/- scale. The Happy, Relaxed, Anxious, Distressed with a yes/no measure of cooperation (HRAD ±) is an observational affect scale developed to clinically assess affect and cooperation during inhalational induction and minor procedures.
Measured: Perioperative/anesthetic induction
Compliance
To measure cooperation and compliance during mask induction, with the ICC (Induction Compliance Checklist). This scale contains a list of 11 behaviors that the child may exhibit when the face mask is placed near them during induction. The score ranges from 0 to 10, with 0 indicating that the child cooperates and shows no mask-rejecting behaviors, and 10 indicating the worst expected response. The higher the score on the ICC scale, the greater the child's rejection of the surgical mask. The authors recommended that a score of 6 or higher be considered traumatic anesthesia.
Measured: Perioperative/anesthetic induction
Caregiver Satisfaction With the Induction Experience
To assess caregiver satisfaction regarding the projector-based software program for mask induction, measured by Parent Satisfaction Survey. This survey consists of a score from 0 to 5; from 0 = very unsatisfied to 5 = very satisfied.
Measured: Perioperative/after anesthetic induction
Long-term behavioral outcomes
To measure incidence of postoperative behavioral outcomes after anesthesia event, measured by Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). The PHBQ is comprised of 27 items among six subscales (general anxiety and regression, separation anxiety, eating disturbance, aggression toward authority, apathy/withdrawal, anxiety about sleep). This method produces a possible range of scores from 27 - 135 (with with higher scores, worse outcomes).
Measured: 2 weeks after surgery
Correlation to HRAD+/- to mYPAS
To measure correlation of HRAD+/- to mYPAS
Measured: Single time point at mask application during anesthetic induction (Day 0, intraoperative)
Correlation to HRAD+/- to ICC
To measure correlation of the cooperation component of HRAD+/- to ICC
Measured: Single time point at mask application during anesthetic induction (Day 0, intraoperative).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 2025Jul 2026

First posted17 Nov 2025
Study start1 Jul 2025
Primary completionDec 2025 (estimated)
Study completionJul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a two-arm, parallel-group superiority trial with 1:1 individual randomization to BERT (a non-pharmacologic audiovisual projection during anesthetic induction) or usual care without BERT. The randomization sequence is created and implemented in REDCap, and group assignment remains concealed until setup in the operating room. The study is open-label-families and clinical staff can tell whether the projection is used-while data analysis is performed by team members who are not involved in delivering the intervention. Enrollment takes place at a single site (Ambulatory Pediatric Surgery Unit, Clínica Alemana de Santiago, Chile). Eligible participants are children 2-6 years scheduled for elective adenotonsillar surgery under general anesthesia. A caregiver is present in both arms. Outcomes are collected during induction on Day 0; caregivers are contacted again 14 days after surgery to complete the PHBQ-AS.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07230743
Sponsor's protocol ID: ID 1483
Status last verified: Nov 2025
First submitted: 8 Sep 2025
Last updated: 17 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared. Given the pediatric, single-center design and small sample size, the risk of re-identification remains non-trivial even after de-identification. In addition, our consent forms do not explicitly authorize external IPD sharing. We will share aggregate numerical results only (e.g., group means, SDs, effect sizes, confidence intervals) in publications and on ClinicalTrials.gov, and provide the protocol and SAP upon request.

Publications

Jenkins BN, Kain ZN, Kaplan SH, Stevenson RS, Mayes LC, Guadarrama J, Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Paediatr Anaesth. 2015 Jul;25(7):738-45. doi: 10.1111/pan.12678. Epub 2015 May 9.
PubMed 25958978
Rodriguez ST, Jang O, Hernandez JM, George AJ, Caruso TJ, Simons LE. Varying screen size for passive video distraction during induction of anesthesia in low-risk children: A pilot randomized controlled trial. Paediatr Anaesth. 2019 Jun;29(6):648-655. doi: 10.1111/pan.13636. Epub 2019 Apr 14.
PubMed 30916447
Fefferman MS, Fraser AE, Takemoto CM, Menendez A, Graetz TJ, Beres AL. Prospective, observational validation of HRAD±, a novel pediatric affect and cooperation scale. Paediatric Anaesthesia. 2024;34(4):376-384.
Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
PubMed 9322455
Jerez-Molina C, Lazaro-Alcay JJ, Ullan-de la Fuente AM. Transcultural adaptation into Spanish of the Induction Compliance Checklist for assessing children's behaviour during induction of anaesthesia. Enferm Clin (Engl Ed). 2017 Oct 17:S1130-8621(17)30142-0. doi: 10.1016/j.enfcli.2017.08.006. Online ahead of print. English, Spanish.
PubMed 29054560
Jerez C, Ullan AM, Lazaro JJ. Reliability and validity of the Spanish version of the modified Yale Preoperative Anxiety Scale. Rev Esp Anestesiol Reanim. 2016 Jun-Jul;63(6):320-6. doi: 10.1016/j.redar.2015.09.006. Epub 2015 Nov 26. English, Spanish.
PubMed 26633606
Yun R, Caruso TJ. Identification and Treatment of Pediatric Perioperative Anxiety. Anesthesiology. 2024 Nov 1;141(5):973-983. doi: 10.1097/ALN.0000000000005105. No abstract available.
PubMed 39163600
Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
PubMed 15562048
Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
PubMed 16882820
Vieco-Garcia A, Lopez-Picado A, Fuentes M, Francisco-Gonzalez L, Joyanes B, Soto C, Garcia de la Aldea A, Gonzalez-Perrino C, Aleo E. Comparison of different scales for the evaluation of anxiety and compliance with anesthetic induction in children undergoing scheduled major outpatient surgery. Perioper Med (Lond). 2021 Dec 14;10(1):58. doi: 10.1186/s13741-021-00228-x.
PubMed 34903293

Interested in taking part?

Ximena Mora Diez, MD

+569 95377637

xmora@alemana.cl

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Anxiety During Mask Induction of Anesthesia in Pediatric Patients With an Immersive/Interactive Technological Intervention Versus Traditional Care: A Latin American Experience
ClinicalTrials.gov ID: NCT07230743
Acronym / sponsor ID: ID 1483
Conditions: Anxiety, Anxiety After Surgery, Induction of Anesthesia, Anxiety Preoperative, Anesthesia Care, Technology Use
Keywords: Custom Projector-based Software Game, Pediatric Mask Induction Anxiety
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 70 participants (estimated)
Lead sponsor: Clinica Alemana de SantiagoUniversity, hospital or other
Collaborators: Universidad del Desarrollo
Study start: 1 Jul 2025 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Jul 2026 (estimated)
First posted: 17 Nov 2025 (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.

Detailed description

Study type: Prospective, comparative clinical trial. Randomization: Simple randomization in a 1:1 ratio using an electronic sequence generated and administered in REDCap®.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: This is a two-arm, parallel-group superiority trial with 1:1 individual randomization to BERT (a non-pharmacologic audiovisual projection during anesthetic induction) or usual care without BERT. The randomization sequence is created and implemented in REDCap, and group assignment remains concealed until setup in the operating room. The study is open-label-families and clinical staff can tell whether the projection is used-while data analysis is performed by team members who are not involved in delivering the intervention. Enrollment takes place at a single site (Ambulatory Pediatric Surgery Unit, Clínica Alemana de Santiago, Chile). Eligible participants are children 2-6 years scheduled for elective adenotonsillar surgery under general anesthesia. A caregiver is present in both arms. Outcomes are collected during induction on Day 0; caregivers are contacted again 14 days after surgery to complete the PHBQ-AS.

Arm	Type	Receives
Standard Parent-Present Induction (PPI)	Active comparator	Other: Standard Parent-Present Induction (PPI)Participants in the Standard PPI group will undergo routine mask induction of anesthesia accompanied by a parent, with no additional structured distraction.
Technology Intervention group	Experimental	Device: Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA), Other: Standard Parent-Present Induction (PPI)Participants in the Technology Intervention group will receive the same parent-present induction, with the addition of a custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA). The interactive audiovisual content is displayed on a large projection screen strategically placed at the foot of the operating table to ensure optimal visibility for the pediatric patient. Children will be instructed to watch and engage with the content as they enter the operating room and throughout the induction process.

Who may qualify

Ages: 2 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Patients undergoing elective procedures under general anesthesia at Clinica Alemana
Parent or caregiver presence for mask induction
ASA I, II
Ages 2-6 years of age
Spanish speaking

Key exclusion criteria (7 listed)

Patient or parental does not consent
ASA ≥ III
Emergency surgery
Intravenous induction of anesthesia
Patient with a significant neurological condition or major developmental disability

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
Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA)Also: BERTThe interactive audiovisual content is displayed on a large projection screen strategically placed at the foot of the operating table to ensure optimal visibility for the pediatric patient. Children will be instructed to watch and engage with the content as they enter the operating room and throughout the induction process. The intervention is designed to promote engagement and reduce perioperative anxiety. Research assistants will set up and operate the projection system and ensure appropriate timing and delivery. Caregivers and OR personnel will be permitted to interact with the child as usual during induction. The video intervention concludes upon loss of consciousness, at which point standard perioperative care resumes.	Device	Technology Intervention group
Standard Parent-Present Induction (PPI)Participants in the Standard PPI group will undergo routine mask induction of anesthesia accompanied by a parent, with no additional structured distraction.	Other	Standard Parent-Present Induction (PPI), Technology Intervention group

Primary outcome

Pediatric anxiety
Time frame: Perioperative/anesthetic induction
Pediatric anxiety levels during mask induction as measured through the Modified Yale Preoperative Anxiety Scale (mYPAS). The Modified Yale Preoperative Anxiety Scale (mYPAS) is a 22-item checklist divided into five categories: "activity," "vocalization," "emotional expressiveness," "apparent arousal," and "relationship with parents." Each category consists of a list of interrelated behaviors, the most representative of which is the score for that category. The mYPAS score ranges from 23.3 to 100; the threshold for considering patients with anxiety is > 30.

6 secondary outcomes

Affect and Cooperation
Time frame: Perioperative/anesthetic induction
Compliance
Time frame: Perioperative/anesthetic induction
Caregiver Satisfaction With the Induction Experience
Time frame: Perioperative/after anesthetic induction
Long-term behavioral outcomes
Time frame: 2 weeks after surgery
Correlation to HRAD+/- to mYPAS
Time frame: Single time point at mask application during anesthetic induction (Day 0, intraoperative)
Correlation to HRAD+/- to ICC
Time frame: Single time point at mask application during anesthetic induction (Day 0, intraoperative).

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 17 Nov 2025.
Background: PubMed 25958978Jenkins BN, Kain ZN, Kaplan SH, Stevenson RS, Mayes LC, Guadarrama J, Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Paediatr Anaesth. 2015 Jul;25(7):738-45. doi: 10.1111/pan.12678. Epub 2015 May 9.
Background: PubMed 30916447Rodriguez ST, Jang O, Hernandez JM, George AJ, Caruso TJ, Simons LE. Varying screen size for passive video distraction during induction of anesthesia in low-risk children: A pilot randomized controlled trial. Paediatr Anaesth. 2019 Jun;29(6):648-655. doi: 10.1111/pan.13636. Epub 2019 Apr 14.
BackgroundFefferman MS, Fraser AE, Takemoto CM, Menendez A, Graetz TJ, Beres AL. Prospective, observational validation of HRAD±, a novel pediatric affect and cooperation scale. Paediatric Anaesthesia. 2024;34(4):376-384.
Background: PubMed 9322455Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
Background: PubMed 29054560Jerez-Molina C, Lazaro-Alcay JJ, Ullan-de la Fuente AM. Transcultural adaptation into Spanish of the Induction Compliance Checklist for assessing children's behaviour during induction of anaesthesia. Enferm Clin (Engl Ed). 2017 Oct 17:S1130-8621(17)30142-0. doi: 10.1016/j.enfcli.2017.08.006. Online ahead of print. English, Spanish.
Background: PubMed 26633606Jerez C, Ullan AM, Lazaro JJ. Reliability and validity of the Spanish version of the modified Yale Preoperative Anxiety Scale. Rev Esp Anestesiol Reanim. 2016 Jun-Jul;63(6):320-6. doi: 10.1016/j.redar.2015.09.006. Epub 2015 Nov 26. English, Spanish.
Background: PubMed 39163600Yun R, Caruso TJ. Identification and Treatment of Pediatric Perioperative Anxiety. Anesthesiology. 2024 Nov 1;141(5):973-983. doi: 10.1097/ALN.0000000000005105. No abstract available.
Background: PubMed 15562048Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
Background: PubMed 16882820Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
Background: PubMed 34903293Vieco-Garcia A, Lopez-Picado A, Fuentes M, Francisco-Gonzalez L, Joyanes B, Soto C, Garcia de la Aldea A, Gonzalez-Perrino C, Aleo E. Comparison of different scales for the evaluation of anxiety and compliance with anesthetic induction in children undergoing scheduled major outpatient surgery. Perioper Med (Lond). 2021 Dec 14;10(1):58. doi: 10.1186/s13741-021-00228-x.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Given the pediatric, single-center design and small sample size, the risk of re-identification remains non-trivial even after de-identification. In addition, our consent forms do not explicitly authorize external IPD sharing. We will share aggregate numerical results only (e.g., group means, SDs, effect sizes, confidence intervals) in publications and on ClinicalTrials.gov, and provide the protocol and SAP upon request.

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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.

Ximena Mora Diez, MD contact

+569 95377637

xmora@alemana.cl

Rodrigo Guiloff Krauss, MD contact

56 222101111 ext. 6223

rguilofk@udd.cl

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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 17 Nov 2025. 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 Chile. 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 Ximena Mora Diez, MD (+569 95377637, xmora@alemana.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pediatric anxiety (time frame: Perioperative/anesthetic induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07230743, which also lists 10 linked publications.

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 17 Nov 2025.