Clinical trial NCT06972420: Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
Official title: Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety at Induction of Pediatric Anesthesia
Keywords: Anxiety at induction
Preoperative anxiety
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study is a monocentric, pilot, exploratory, open-label, prospective quasi-experimental "before/after" study
Primary purpose: PREVENTION

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).

Primary outcomes:
measure: Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS
timeFrame: Day 1 ( Anesthesia induction and surgery)
Secondary outcomes:
measure: Children's compliance during induction as assessed by the Induction Compliance Checklist
timeFrame: Day 1 (Anesthesia induction)
measure: Time spent in the PACU
timeFrame: Day 1 ( From arrival in the PACU until return to the hospital room)
measure: Postoperative delirium as assessed by the PAED Scale
timeFrame: Day 1 (After surgery)
measure: Postoperative pain as assessed by the VAS scale
timeFrame: Day 1 (After surgery)
measure: Postoperative pain as assessed by the FLACC scale.
timeFrame: Day 1 (After surgery)
measure: Postoperative pain as assessed by the PPMP scale
timeFrame: Day 2 and 5 after sugery
measure: Behavioral assessment
timeFrame: Day 1, 2 and 5 after sugery
measure: Parental satisfaction
timeFrame: At the day of patiet sicharge or Day 14 postoperatevly
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: François CREMIEUX
role: STUDY_DIRECTOR
References: