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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Anxiety at Induction of Pediatric Anesthesia

Treatments: Behavioral: Hypnosis session

Study type: Interventional

Funder types: Other

Identifiers

NCT06972420

2024-A02469-38

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Part 2: Standard preoperative care before anesthesia induction

No Intervention group

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.

Parti 1: Preoperative care combined with a hypnosis session

Experimental group

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.

Treatment:

Behavioral: Hypnosis session