Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypnosis session.
- Who it may be relevant to
- Registry conditions: Anxiety at Induction of Pediatric Anesthesia. Basic parameters: 5 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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 c
Primary outcome measures
- Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS [Time frame: Day 1 ( Anesthesia induction and surgery)]
Secondary outcome measures (8)
- Children's compliance during induction as assessed by the Induction Compliance Checklist [Time frame: Day 1 (Anesthesia induction)]
- Time spent in the PACU [Time frame: Day 1 ( From arrival in the PACU until return to the hospital room)]
- Postoperative delirium as assessed by the PAED Scale [Time frame: Day 1 (After surgery)]
- Postoperative pain as assessed by the VAS scale [Time frame: Day 1 (After surgery)]
- Postoperative pain as assessed by the FLACC scale. [Time frame: Day 1 (After surgery)]
- Postoperative pain as assessed by the PPMP scale [Time frame: Day 2 and 5 after sugery]
- Behavioral assessment [Time frame: Day 1, 2 and 5 after sugery]
- Parental satisfaction [Time frame: At the day of patiet sicharge or Day 14 postoperatevly]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- Assistance Publique Hôpitaux de Marseille — Marseille
Identifiers
NCT: NCT06972420 · 2024-A02469-38