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).

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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. The intervention is designed to promote engagement and reduce perioperative anxiety. Research assistants will set up and operate the projection system and ensure appropriate
• Другое 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.

Первичные конечные точки

• Pediatric anxiety [Срок оценки: Perioperative/anesthetic induction]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Clínica Alemana de Santiago — Vitacura

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 15562048

Идентификаторы

NCT: NCT07230743 · ID 1483

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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