RecruitingNAINTERVENTIONAL

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

Going into hospital for an operation can be worrying for children and their parents. This study wants to find out if giving children between 5 and 12 years old a special visit from a trained nurse before their surgery can help reduce their anxiety. The nurse's visit would involve explaining things clearly and leading a relaxation session, sometimes called 'hypnosis'. The study would compare two groups of children. One group would receive the usual care before surgery, while the other group would have this extra visit and relaxation session. Researchers will measure how anxious the children are when they go into the operating room, hoping to find ways to make the experience more comfortable and less stressful for young patients.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique Hopitaux De Marseille

Enrolment target

Start

02 Jul 2025

Estimated completion

02 Oct 2026

Anxiety at Induction of Pediatric Anesthesia

What is this study about?

When children need an operation, it's completely normal for them and their parents to feel a bit anxious or worried. This feeling, sometimes called 'preoperative anxiety', can affect how a child recovers and their overall experience in hospital. This study is exploring a new way to help children aged 5 to 12 feel calmer and more comfortable before their surgery.

The research looks at whether a special preparation program can make a difference. This program includes a visit from a trained nurse anesthetist – a nurse specially trained in giving anaesthetic and looking after children during operations. During this visit, which happens a couple of weeks before the surgery, the nurse will take around 30 minutes to talk to the child. They'll spend some time going over what to expect and answering any questions, making sure everything is clear.

The second part of the visit involves a relaxation session, sometimes referred to as 'hypnosis'. This isn't like stage hypnosis; it's a gentle technique to help children relax and focus, making them feel more at ease. The study compares children who receive this extra visit and relaxation session with children who receive the standard care. The main goal is to see if this new approach helps reduce children's stress and anxiety when they arrive in the operating room for their procedure.

Key takeaways

Aims to reduce anxiety in children (5-12) before surgery.
Tests if a special nurse visit with relaxation helps.
Compares enhanced care to standard hospital care.
Focuses on improving the child's hospital experience.
Participation involves anxiety checks; some get an extra relaxation session.

Who may be eligible?

This study is looking for children aged between 5 and 12 years old who are scheduled to have an operation that requires them to stay in hospital for at least one night. This could include many types of surgery, such as those for tummy issues, bladder problems, ear, nose, and throat procedures, plastic surgery, or bone operations like correcting scoliosis.

For a child to take part, their parents or legal guardians must give their written permission and also agree to fill out some questionnaires. It's important that the child can speak and understand language well enough to communicate.

However, some children won't be able to join the study. This includes those with certain learning difficulties, children who regularly have general anaesthetics for ongoing medical conditions, those needing urgent emergency surgery, or children who have been diagnosed with certain mental health conditions or autism. The study aims to focus on children with typical development and scheduled surgeries.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 5 and 12 years old?
Is your child having an operation that needs them to stay in hospital at least one night?
Can your child speak and understand language well?
Does your child NOT regularly need general anaesthetics for a medical condition?
Is your child NOT having emergency surgery?
Has your child NOT been diagnosed with learning difficulties, mental health conditions, or autism?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, their experience would depend on which group they are in. Some children will receive the standard care, which means they will get the usual preparation for surgery that the hospital provides. Their anxiety levels will be checked just before the operation in the operating room.

Other children will receive an extra step. About two weeks before their surgery, a trained nurse anesthetist will visit them for about 30 minutes. This visit is in addition to their regular appointments with the doctor. During this visit, the nurse will spend 10 minutes checking your understanding of the surgery and asking if you have any questions. Then, for 20 minutes, they will lead a special relaxation session, sometimes called 'hypnosis', to help your child feel calm. Just like the other group, their anxiety levels will also be measured when they go into the operating room.

The total duration of your child's involvement would be from the time of the early nurse visit (if applicable) until just before their surgery. There are no special medications involved, only the assessment of anxiety and the potential extra relaxation session.

Potential risks and benefits

Taking part in this study could potentially benefit your child by providing them with an enhanced preparation for surgery, which might lead to them feeling less anxious and stressed. The relaxation techniques offered are gentle and aim to help children feel more at ease. For those in the standard care group, participation helps researchers understand current anxiety levels, which can improve future care. As for risks, the special relaxation session is not expected to have any negative effects. There are no experimental medications involved, and all children will receive appropriate medical care for their surgery. You and your child are entirely free to withdraw from the study at any time without giving a reason, and this will not affect the medical care your child receives.

Locations (1)

Assistance Publique Hôpitaux de Marseille
Verified postcode
Marseille, France· Recruiting

Common questions

What is 'hypnosis' in this study?

It's a gentle relaxation technique to help children feel calm and focused, not like stage hypnosis. It helps them feel more at ease before surgery.

Will my child get special medication?

No, this study does not involve any special medicines. It focuses on preparation and relaxation techniques.

Can I choose which group my child is in?

No, which group your child is in will be decided randomly, like flipping a coin. This helps make the study results fair.

Will taking part affect my child's surgery?

No, your child's medical care and planned surgery will not be affected by taking part in this study.

Who is the nurse who visits my child?

It's a nurse anesthetist specially trained in giving anaesthetic to children and also trained in these relaxation techniques.

How to find out more

Fleur Vincent-Jabouille

fleur.vincent-jabouille@ap-hm.fr +33 (0) 4 91 38 63 28 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.