Reducing children's anxiety before anesthesia induction
Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
This project will try adding a 30-minute hypnosis visit by a nurse trained in pediatric hypnosis to standard preoperative care to see if it reduces anxiety in children aged 5–12 having planned surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06972420 on ClinicalTrials.gov |
What this trial studies
The trial compares two sequential phases: a 'before' phase with standard preoperative care and an 'after' phase in which patients also receive a 30-minute hypnosis session from a nurse anesthetist trained in working with children and families. Anxiety levels are measured at the time of anesthesia induction in the operating room to capture the perioperative response. The hypnosis visit is delivered within the two weeks prior to surgery and complements existing anesthesia consultation procedures. The single-center project is run at Assistance Publique Hôpitaux de Marseille and excludes children with developmental, autistic or psychiatric disorders, emergency surgery, or those requiring routine general anesthesia.
Who should consider this trial
Good fit: Children aged 5–12 scheduled for elective inpatient surgery who have parental consent and no cognitive, autism spectrum, or psychiatric disorders are ideal candidates.
Not a fit: Children under 5, those with developmental or autism spectrum disorders, emergency cases, or patients who require ongoing regular general anesthesia are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could reduce preoperative anxiety and improve the child’s experience and cooperation at anesthesia induction, potentially smoothing perioperative care.
How similar studies have performed: Prior smaller studies and clinical reports of preoperative preparation and clinical hypnosis in children have shown promise in reducing anxiety, but large randomized trials remain limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Marseille
- Assistance Publique Hôpitaux de Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Fleur Vincent-Jabouille
- Email: Fleur.VINCENT-JABOUILLE@ap-hm.fr
- Phone: +33 (0) 4 91 38 63 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.