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Recruiting Not applicable

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

NCT06972420 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-07-02
Last updated
2025-09-22

Condition(s) studied

Anxiety at Induction of Pediatric Anesthesia

Investigational drug(s) / intervention(s)

Hypnosis session

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.

Study 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

Sex
ALL
Min age
5 Years
Max age
12 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS — 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.

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique Hôpitaux de Marseille Marseille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06972420 on ClinicalTrials.gov ↗ ← All trials in France