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L'essai clinique NCT06972420 (QUALIN) pour Anxiety at Induction of Pediatric Anesthesia est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room (QUALIN)
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L'étude clinique NCT06972420 (QUALIN) est un essai interventionnel pour Anxiety at Induction of Pediatric Anesthesia. Son statut actuel est : en recrutement. L'étude a débuté le 2 juillet 2025 et vise à recruter 60 participants. Dirigé par Assistance Publique Hopitaux De Marseille, l'essai devrait être terminé d'ici le 2 octobre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 22 septembre 2025.
Résumé succinct
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.
Titre officiel
Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
Conditions
Anxiety at Induction of Pediatric AnesthesiaAutres identifiants de l'essai
- QUALIN
- 2024-A02469-38
Numéro NCT
Date de début (réel)
2025-07-02
Dernière mise à jour publiée
2025-09-22
Date de fin (estimée)
2026-10-02
Inscription (estimée)
60
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Anxiety at induction
Preoperative anxiety
Preoperative anxiety
Objectif principal
Prévention
Plan d'attribution
Non aléatoire
Modèle d'intervention
Séquentiel
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Aucune interventionPart 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. | N/A |
ExpérimentalParti 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. | Hypnosis Session 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS | 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. | Day 1 ( Anesthesia induction and surgery) |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Children's compliance during induction as assessed by the Induction Compliance Checklist | Induction compliance check list at the time of anesthetic induction | Day 1 (Anesthesia induction) |
Time spent in the PACU | Duration in minutes between arrival in the PACU and return to the hospital room | Day 1 ( From arrival in the PACU until return to the hospital room) |
Postoperative delirium as assessed by the PAED Scale | Assessed in the PACU using the PAED scale (Pediatric Anesthesia Emergence Delirium). | Day 1 (After surgery) |
Postoperative pain as assessed by the VAS scale | 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. | Day 1 (After surgery) |
Postoperative pain as assessed by the FLACC scale. | 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. | Day 1 (After surgery) |
Postoperative pain as assessed by the PPMP scale | 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 | Day 2 and 5 after sugery |
Behavioral assessment | 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. | Day 1, 2 and 5 after sugery |
Parental satisfaction | Assessed via a dedicated questionnaire, either in the hospital or through a phone call | At the day of patiet sicharge or Day 14 postoperatevly |
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
5 Years
Sexes éligibles
Tous
- 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
- 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).
Assistance Publique Hopitaux De MarseilleContact central de l'essai
Contact: Fleur Vincent-Jabouille, +33 (0) 4 91 38 63 28, [email protected]
1 Centres de l'essai dans 1 pays
Assistance Publique Hôpitaux de Marseille, Marseille, 13005, France
Vincent-Jabouille Fleur, Contact, +33 (0) 4 91 38 63 28, [email protected]
Vincent-Jabouille Fleur, Investigateur principal
Dr Matthieu Laborier, Investigateur associé
En recrutement