Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
Anxiety at Induction of Pediatric Anesthesia
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 5 años - 12 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 60 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Preoperative anxiety refers to a range of physical and/or psychological manifestations, which can have a significant impact on medical outcomes and the experience of the child and their parents. This study aims to evaluate the impact of preoperative preparation combined with a hypnosis session conducted by nurse anesthetists (IADE) trained in working with children and their families. The goal is to improve the child's experience and reduce perioperative anxiety and stress.
It is divided into two phases:
- First phase, called "Before": Standard preoperative care is provided according to the existing protocol in the department. Anxiety levels will be measured at the time of induction in the operating room.
- Second phase, called "After": In the two weeks prior to surgery, in addition to the standard preoperative care currently in place, the patient will receive a 30-minute visit from a nurse anesthetist trained in hypnosis. This is an added procedure complementing the anesthesia consultation. The visit is divided into two parts: 10 minutes to review and clarify the explanations given by the anesthesiologist and surgeon, and 20 minutes of a formal hypnosis session. A personalized liaison form will be completed to facilitate communication between the consultation and the operating room. Anxiety levels will again be measured at the time of induction.
¿Quién podría participar?
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Inclusion Criteria:
- Children aged between 5 and 12 years, i.e., able to engage in verbal communication;
- Scheduled for surgery requiring hospitalization at least one day prior to the procedure, including but not limited to gastrointestinal or urological surgery, ENT procedures, plastic interventions, and orthopedic surgery (e.g., scoliosis correction);
- Provision of written informed consent by the parents or legal guardians (or by the sole parent/legal guardian, where applicable);
- Parental agreement to participate in the study by completing the required questionnaires;Affiliation with or entitlement to a national social security scheme
Exclusion Criteria:
- Patients with cognitive developmental disorders;
- Patients requiring regular general anesthesia as part of ongoing medical management;
- Patients undergoing emergency surgery;
- Patients with a known psychiatric disorder;
- Patients diagnosed with an autism spectrum disorder (ASD).
Tratamiento, grupos y participación
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- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Part 2: Standard preoperative care before anesthesia induction
Part 2: Children aged between 5 and 12 years scheduled for surgery requiring hospitalization, recieving standard preoperative care prior to anesthesia induction. Anxiety levels will be measured at the time of induction in the operating room.
Parti 1: Preoperative care combined with a hypnosis session
Part 1: Children aged between 5 and 12 scheduled for surgery requiring hospitalization, recieving a 20 min hypnosis session within two weeks prior to anesthesia induction in addition to standard preoperative care. Anxiety levels will be measured at the time of induction in the operating room.
Behavioral: Hypnosis session
Hypnosis session BEHAVIORAL
Within the two weeks prior to surgery, in addition to the standard preoperative care currently in place, the patient will receive a 30-minute visit from a nurse anesthetist trained in hypnosis. This is an added procedure complementing the anesthesia consultation. The visit is divided into two parts: 10 minutes to review and clarify the explanations given by the anesthesiologist and surgeon, and 20 minutes of a formal hypnosis session. A personalized liaison form will be completed to facilitate communication between the consultation and the operating room.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS
Plazo: Day 1 ( Anesthesia induction and surgery)
Mesure of the Modified Yale Preoperative Anxiety Scale by anesthetics or surgical nurse. The total score ranges from 23 to 100: children are considered moderately anxious for a score above 24, and highly anxious for a score above 30.
Medidas secundarias
Children's compliance during induction as assessed by the Induction Compliance Checklist
Plazo: Day 1 (Anesthesia induction)
Induction compliance check list at the time of anesthetic induction
Time spent in the PACU
Plazo: Day 1 ( From arrival in the PACU until return to the hospital room)
Duration in minutes between arrival in the PACU and return to the hospital room
Postoperative delirium as assessed by the PAED Scale
Plazo: Day 1 (After surgery)
Assessed in the PACU using the PAED scale (Pediatric Anesthesia Emergence Delirium).
Postoperative pain as assessed by the VAS scale
Plazo: Day 1 (After surgery)
Evaluated in the recovery room using the Visual Analogue Scale (VAS). Total scole ranging from 0 to 10 where a higher scores mean worse pain.
Postoperative pain as assessed by the FLACC scale.
Plazo: Day 1 (After surgery)
Evaluated in the recovery room using the Face Legs Activity Cry Consolability (FLACC) scale. Total scole ranging from 0 to 10 where a higher scores mean worse pain.
Postoperative pain as assessed by the PPMP scale
Plazo: Day 2 and 5 after sugery
Assessed by parents on postoperative days 2 and 5 using the Parents' Postoperative Pain Measure (PPPM), either during hospitalization or via telephone follow-up. The score ranges from 0 to 15, where a higher scire mean worse pain
Behavioral assessment
Plazo: Day 1, 2 and 5 after sugery
The child's postoperative behavior will be assessed on postoperative days 2, 5, and 14 using the PHBQ (Post-Hospitalization Behavior Questionnaire), either in the hospital or via a phone call.
Parental satisfaction
Plazo: At the day of patiet sicharge or Day 14 postoperatevly
Assessed via a dedicated questionnaire, either in the hospital or through a phone call
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Assistance Publique Hôpitaux de MarseilleMarseille, FranceEstado desconocido
Equipo y fechas
- Patrocinador principal
- Assistance Publique Hopitaux De Marseille
- Inicio del estudio
- 2 jul 2025 Real
- Finalización primaria
- 8 ene 2026 Real
- Finalización del estudio
- 8 ene 2026 Real
- Primera publicación
- 15 may 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026