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Search / Trial NCT06972420

Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · May 13, 2025

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

Anxiety At Induction Preoperative Anxiety

ClinConnect Summary

This clinical trial is looking at ways to help children feel less anxious before they have surgery. Many kids feel scared or nervous when they are about to receive anesthesia, which is the medicine that makes them sleep during the operation. The study is testing a new approach that includes a special preparation session with a trained nurse who uses hypnosis to help ease this anxiety. The goal is to make the surgery experience better for both the child and their parents, by reducing stress and worry.

To be eligible for this study, children need to be between 5 and 12 years old, able to talk, and scheduled for a surgery that requires at least one night in the hospital. The study includes two parts: first, the usual care will be provided, and anxiety levels will be checked. Then, in the two weeks before surgery, the child will have a 30-minute visit with the nurse anesthetist, where they will discuss the surgery and go through a hypnosis session. This is designed to help prepare the child and lower anxiety levels when it's time for the surgery. Parents will need to give permission for their child to participate, and they will be asked to fill out some questionnaires about their child's experience.

Gender

ALL

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).

About Assistance Publique Hopitaux De Marseille

Assistance Publique - Hôpitaux de Marseille (AP-HM) is a leading public healthcare institution in France, dedicated to providing high-quality medical care and advancing research in various clinical fields. As a prominent sponsor of clinical trials, AP-HM is committed to fostering innovation and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary approach, the institution collaborates with a network of healthcare professionals, researchers, and academic partners to facilitate cutting-edge studies that address critical health challenges. AP-HM's dedication to ethical standards and patient safety underscores its role as a trusted leader in clinical research and healthcare delivery.

Locations

Marseille, , France

Patients applied

0 patients applied

Trial Officials

François CREMIEUX

Study Director

Assistance Publique Hopitaux De Marseille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported