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

NCT06972420 | Recruiting

• 1 other identifier: 2024-A02469-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety at Induction of Pediatric Anesthesia

Keywords

Anxiety at induction; Preoperative anxiety

Outcome Measures

Primary Outcomes (1)

• Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS

  Mesure of the Modified Yale Preoperative Anxiety Scale by anesthetics or surgical nurse. The total score ranges from 23 to 100: children are considered moderately anxious for a score above 24, and highly anxious for a score above 30.

  Day 1 ( Anesthesia induction and surgery)

Secondary Outcomes (8)

• Children's compliance during induction as assessed by the Induction Compliance Checklist

  Day 1 (Anesthesia induction)

• Time spent in the PACU

  Day 1 ( From arrival in the PACU until return to the hospital room)

• Postoperative delirium as assessed by the PAED Scale

  Day 1 (After surgery)

• Postoperative pain as assessed by the VAS scale

  Day 1 (After surgery)

• Postoperative pain as assessed by the FLACC scale.

  Day 1 (After surgery)

Study Arms (2)

Part 2: Standard preoperative care before anesthesia induction

NO INTERVENTION

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

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.

Behavioral: Hypnosis session

Interventions

Hypnosis session BEHAVIORAL

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 communication between the consultation and the operating room.

Parti 1: Preoperative care combined with a hypnosis session

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

Study Officials

• François CREMIEUX

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

Fleur Vincent-Jabouille

CONTACT

+33 (0) 4 91 38 63 28; Fleur.VINCENT-JABOUILLE@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a monocentric, pilot, exploratory, open-label, prospective quasi-experimental "before/after" study

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 15, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): October 2, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)