Not yet recruitingNAINTERVENTIONAL

Non-medicinal Technique and Dyspnea in Weaning Patients

This study, called "Non-medicinal Technique and Dyspnea in Weaning Patients," is for people in intensive care (ICU) who have been on a breathing machine for at least 24 hours and are finding it hard to be weaned off. It aims to see if using medical hypnosis can help reduce their shortness of breath (dyspnea) when they try to breathe on their own. Researchers will compare patients who receive hypnosis before their breathing tests with those who receive standard care. The main goal is to find out if hypnosis makes a significant difference in how breathless patients feel, using a simple daily score they give themselves. This research is open to all adults aged 18 and over.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

01 Jun 2025

Estimated completion

01 Jun 2027

Difficult Mechanical Ventilation Weaning Spontaneous Breathing Trial Dyspnea

What is this study about?

Imagine you're in the intensive care unit (ICU) and have been on a breathing machine for a while. The medical team is trying to help you slowly get used to breathing on your own again. This process is called 'weaning.' Sometimes, it can be quite challenging, and patients might feel very short of breath – this is known as dyspnea.

This study is looking into a gentle, non-drug approach: medical hypnosis. The main idea is to see if having a short session of hypnosis each day, before trying to breathe on your own, can help patients feel less breathless. The researchers will compare this approach with the usual care, where patients receive regular support without hypnosis. The hope is that hypnosis might make the weaning process a bit easier and more comfortable for patients.

So, what does this actually mean? Patients taking part will be divided into two groups. One group will get the usual care and support. The other group will get the usual care plus a daily hypnosis session. Over seven days, or until they can breathe on their own, patients will be asked to rate how breathless they feel. By comparing these scores between the two groups, the doctors hope to understand if medical hypnosis is a helpful tool for people struggling to come off a breathing machine.

Key takeaways

The study tests if medical hypnosis helps reduce breathlessness.
It's for ICU patients struggling to come off a breathing machine.
You'll either receive standard care or standard care plus daily hypnosis.
Patients will rate their breathlessness each day for up to 7 days.
It aims to make the breathing machine weaning process easier.
Participation is voluntary and you can leave at any time.

Who may be eligible?

To be able to take part in this study, you need to be an adult (18 years or older) currently in the intensive care unit. You must have been on a breathing machine for at least 24 hours and have found it difficult to breathe on your own during a previous attempt.

There are several reasons why you might not be able to join the study. For example, if you've already been successfully taken off a breathing machine during this hospital stay, or if you have a special tube in your throat for breathing (a tracheostomy). Certain long-term muscle or nerve conditions, serious recent brain injuries (like a stroke less than three months ago), or some mental health conditions that require medication might also mean you can't participate.

Other reasons for not being eligible include being pregnant or breastfeeding, not being able to understand French (if that's the language of the study), or if your doctors have decided against further intensive treatments. Also, if you have severe confusion or hearing difficulties, or if you're already in another similar study, you wouldn't be able to join this one.

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.

Are you 18 years old or older?
Are you currently in the intensive care unit (ICU)?
Have you been on a breathing machine for at least 24 hours?
Have you tried to breathe on your own before and found it difficult?
Are you able to speak and understand French (if applicable for the study location)?
Do you have any long-term muscle/nerve conditions or recent serious brain injury?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two groups. One group will receive the standard care given in the intensive care unit to help you with your breathing. The other group will receive this standard care plus a daily session of medical hypnosis. These sessions will happen every day for up to seven days, or until you're able to breathe without the machine. On each of these days, just before your breathing test, you'll be asked to rate how breathless you're feeling using a simple scale. There are no extra visits or medications involved outside of your usual care, beyond the hypnosis sessions for one group and the breathlessness assessment for both.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from feeling less breathless during the process of coming off the breathing machine, especially if you're in the hypnosis group. However, there's no guarantee this study will directly improve your health. Risks are generally low for this type of non-drug intervention, but as with any medical procedure, there's always a small chance of unforeseen effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Hôpital de Fleyriat - Centre hospitalier de Bourg-en-Bresse - Réanimation Soins continus
Verified postcode
Bourg-en-Bresse, France
CHU Clermont Ferrand - Hôpital Gabriel Montpied - Médecine Intensive Réanimation
Verified postcode
Clermont-Ferrand, France
CHU Grenoble Alpes - Hôpital Michallon - Médecine Intensive Réanimation
Verified postcode
La Tronche, France
Hospices Civils de Lyon - Hôpital de la Croix Rousse - Médecine Intensive Réanimation
Verified postcode
Lyon, France
Hospices Civils de Lyon - Hôpital Lyon Sud - Réanimation Polyvalente
Verified postcode
Pierre-Bénite, France

Common questions

What is 'dyspnea'?

Dyspnea is simply the medical word for shortness of breath or feeling breathless.

What is 'mechanical ventilation weaning'?

This is the process where doctors slowly help you stop using a breathing machine and start breathing entirely on your own again.

What is medical hypnosis?

It's a focused, relaxed state led by a trained professional, used to help manage symptoms like breathlessness or anxiety. It's not like stage hypnosis.

Will I have to pay to be in the study?

No, you will not have to pay to participate in this study. All study treatments and assessments are provided free of charge.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Christelle TOMBALIAN

ghn.easywean@chu-lyon.fr + 33 4 26 10 92 65 Official trial record

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