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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

5 years - 12 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

60 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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).

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Assistance Publique Hopitaux De Marseille

Study start

Jul 2, 2025 Actual

Primary completion

Jan 8, 2026 Actual

Study completion

Jan 8, 2026 Actual

First posted

May 15, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.