Anxiety at Induction of Pediatric AnesthesiaQUALINNCT06972420
Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
A study testing Hypnosis session in people with Anxiety at Induction of Pediatric Anesthesia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Anxiety at Induction of Pediatric Anesthesia
- What is being tested?
- Hypnosis session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2025to 2 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fleur Vincent-Jabouille contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Vincent-Jabouille Fleur, +33 (0) 4 91 38 63 28, Fleur.VINCENT-JABOUILLE@ap-hm.fr
Vincent-Jabouille Fleur
About this study
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.
- Being tested
- Hypnosis session
- Keywords
- Anxiety at induction, Preoperative anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Hypnosis session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 ( Anesthesia induction and surgery)
Secondary outcomes (8)
Children's compliance during induction as assessed by the Induction Compliance Checklist
Induction compliance check list at the time of anesthetic induction
Measured: Day 1 (Anesthesia induction)
Time spent in the PACU
Duration in minutes between arrival in the PACU and return to the hospital room
Measured: Day 1 ( From arrival in the PACU until return to the hospital room)
Postoperative delirium as assessed by the PAED Scale
Assessed in the PACU using the PAED scale (Pediatric Anesthesia Emergence Delirium).
Measured: Day 1 (After surgery)
Postoperative pain as assessed by the VAS scale
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.
Measured: Day 1 (After surgery)
Postoperative pain as assessed by the FLACC scale.
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.
Measured: Day 1 (After surgery)
Postoperative pain as assessed by the PPMP scale
Assessed 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
Measured: Day 2 and 5 after sugery
Behavioral assessment
The 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.
Measured: Day 1, 2 and 5 after sugery
Parental satisfaction
Assessed via a dedicated questionnaire, either in the hospital or through a phone call
Measured: At the day of patiet sicharge or Day 14 postoperatevly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start2 Jul 2025
- Primary completion2 Oct 2026 (estimated)
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety at Induction of Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study is a monocentric, pilot, exploratory, open-label, prospective quasi-experimental "before/after" study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972420
- Sponsor's protocol ID
- 2024-A02469-38
- Acronym
- QUALIN
- Status last verified
- Sep 2025
- First submitted
- 15 Apr 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
- ClinicalTrials.gov ID
- NCT06972420
- Acronym / sponsor ID
- QUALIN / 2024-A02469-38
- Keywords
- Anxiety at induction, Preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a monocentric, pilot, exploratory, open-label, prospective quasi-experimental "before/after" study
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Hypnosis sessionPart 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis sessionWithin 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. | Behavioural | Parti 1: Preoperative care combined with a hypnosis session |
Primary outcome
Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS
Time frame: Day 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fleur Vincent-Jabouille contact
François CREMIEUX study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis session in people with Anxiety at Induction of Pediatric Anesthesia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fleur Vincent-Jabouille (+33 (0) 4 91 38 63 28 ext. 04 13 42 94 28, Fleur.VINCENT-JABOUILLE@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS (time frame: Day 1 ( Anesthesia induction and surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.