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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06972420
Acronym
QUALIN
Enrollment
60
Registered
2025-05-15
Start date
2025-07-02
Completion date
2026-10-02
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety at Induction of Pediatric Anesthesia

Keywords

Anxiety at induction, Preoperative anxiety

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.

Interventions

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.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPASDay 1 ( Anesthesia induction and surgery)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.

Secondary

MeasureTime frameDescription
Time spent in the PACUDay 1 ( From arrival in the PACU until return to the hospital room)Duration in minutes between arrival in the PACU and return to the hospital room
Postoperative delirium as assessed by the PAED ScaleDay 1 (After surgery)Assessed in the PACU using the PAED scale (Pediatric Anesthesia Emergence Delirium).
Postoperative pain as assessed by the VAS scaleDay 1 (After surgery)Evaluated in the recovery room using the Visual Analogue Scale (VAS). Total scole ranging from 0 to 10 where a higher scores mean worse pain.
Children's compliance during induction as assessed by the Induction Compliance ChecklistDay 1 (Anesthesia induction)Induction compliance check list at the time of anesthetic induction
Postoperative pain as assessed by the PPMP scaleDay 2 and 5 after sugeryAssessed by parents on postoperative days 2 and 5 using the Parents' Postoperative Pain Measure (PPPM), either during hospitalization or via telephone follow-up. The score ranges from 0 to 15, where a higher scire mean worse pain
Behavioral assessmentDay 1, 2 and 5 after sugeryThe child's postoperative behavior will be assessed on postoperative days 2, 5, and 14 using the PHBQ (Post-Hospitalization Behavior Questionnaire), either in the hospital or via a phone call.
Parental satisfactionAt the day of patiet sicharge or Day 14 postoperatevlyAssessed via a dedicated questionnaire, either in the hospital or through a phone call
Postoperative pain as assessed by the FLACC scale.Day 1 (After surgery)Evaluated in the recovery room using the Face Legs Activity Cry Consolability (FLACC) scale. Total scole ranging from 0 to 10 where a higher scores mean worse pain.

Countries

France

Contacts

Primary ContactFleur Vincent-Jabouille
Fleur.VINCENT-JABOUILLE@ap-hm.fr+33 (0) 4 91 38 63 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026