Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06972420
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The study is a monocentric, pilot, exploratory, open-label, prospective quasi-experimental "before/after" study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS", 'timeFrame': 'Day 1 ( Anesthesia induction and surgery)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Children's compliance during induction as assessed by the Induction Compliance Checklist", 'timeFrame': 'Day 1 (Anesthesia induction)', 'description': 'Induction compliance check list at the time of anesthetic induction'}, {'measure': 'Time spent in the PACU', 'timeFrame': 'Day 1 ( From arrival in the PACU until return to the hospital room)', 'description': 'Duration in minutes between arrival in the PACU and return to the hospital room'}, {'measure': 'Postoperative delirium as assessed by the PAED Scale', 'timeFrame': 'Day 1 (After surgery)', 'description': 'Assessed in the PACU using the PAED scale (Pediatric Anesthesia Emergence Delirium).'}, {'measure': 'Postoperative pain as assessed by the VAS scale', 'timeFrame': 'Day 1 (After surgery)', 'description': '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.'}, {'measure': 'Postoperative pain as assessed by the FLACC scale.', 'timeFrame': 'Day 1 (After surgery)', 'description': '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.'}, {'measure': 'Postoperative pain as assessed by the PPMP scale', 'timeFrame': 'Day 2 and 5 after sugery', 'description': "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"}, {'measure': 'Behavioral assessment', 'timeFrame': 'Day 1, 2 and 5 after sugery', 'description': "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."}, {'measure': 'Parental satisfaction', 'timeFrame': 'At the day of patiet sicharge or Day 14 postoperatevly', 'description': 'Assessed via a dedicated questionnaire, either in the hospital or through a phone call'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety at induction', 'Preoperative anxiety'], 'conditions': ['Anxiety at Induction of Pediatric Anesthesia']}, 'descriptionModule': {'briefSummary': '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.\n\nIt is divided into two phases:\n\n* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 5 and 12 years, i.e., able to engage in verbal communication;\n* 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);\n* Provision of written informed consent by the parents or legal guardians (or by the sole parent/legal guardian, where applicable);\n* Parental agreement to participate in the study by completing the required questionnaires;Affiliation with or entitlement to a national social security scheme\n\nExclusion Criteria:\n\n* Patients with cognitive developmental disorders;\n* Patients requiring regular general anesthesia as part of ongoing medical management;\n* Patients undergoing emergency surgery;\n* Patients with a known psychiatric disorder;\n* Patients diagnosed with an autism spectrum disorder (ASD).'}, 'identificationModule': {'nctId': 'NCT06972420', 'acronym': 'QUALIN', 'briefTitle': 'Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room', 'orgStudyIdInfo': {'id': '2024-A02469-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Part 2: Standard preoperative care before anesthesia induction', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Parti 1: Preoperative care combined with a hypnosis session', 'description': '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.', 'interventionNames': ['Behavioral: Hypnosis session']}], 'interventions': [{'name': 'Hypnosis session', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Parti 1: Preoperative care combined with a hypnosis session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent-Jabouille Fleur', 'role': 'CONTACT', 'email': 'Fleur.VINCENT-JABOUILLE@ap-hm.fr', 'phone': '+33 (0) 4 91 38 63 28'}, {'name': 'Vincent-Jabouille Fleur', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr Matthieu Laborier', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Fleur Vincent-Jabouille', 'role': 'CONTACT', 'email': 'Fleur.VINCENT-JABOUILLE@ap-hm.fr', 'phone': '+33 (0) 4 91 38 63 28', 'phoneExt': '04 13 42 94 28'}], 'overallOfficials': [{'name': 'François CREMIEUX', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}