NCT06972420 Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
| NCT ID | NCT06972420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Anxiety at Induction of Pediatric Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2026-10-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-07-02 with a primary completion date of 2026-10-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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).
Contact & Investigator
François CREMIEUX
STUDY DIRECTOR
Assistance Publique Hopitaux De Marseille
Frequently Asked Questions
Who can join the NCT06972420 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Anxiety at Induction of Pediatric Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06972420 currently recruiting?
Yes, NCT06972420 is actively recruiting participants. Contact the research team at Fleur.VINCENT-JABOUILLE@ap-hm.fr for enrollment information.
Where is the NCT06972420 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT06972420 clinical trial?
NCT06972420 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is François CREMIEUX at Assistance Publique Hopitaux De Marseille. The trial plans to enroll 60 participants.
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