RecruitingNAINTERVENTIONAL

Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital

This study at Niort Hospital is exploring how gentle, relaxing touch might help patients in intensive care units. Patients who are on a breathing machine (intubated) and are given calming medicines (sedated) often need these medicines reduced gradually. The study wants to see if receiving gentle touch on their hands, feet, or head twice a day for 30 minutes can help them feel more relaxed and reduce the total amount of calming medicine they need. The aim is to make the process of waking up and having the breathing tube removed smoother and more comfortable for patients. Researchers will compare patients who receive this relaxing touch with those who receive standard care.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier de Niort

Enrolment target

Start

27 Feb 2023

Estimated completion

31 Dec 2025

Reaction Anxiety Difficult or Failed Intubation

What is this study about?

This study is taking place in the intensive care unit at Niort Hospital. It's looking into whether a simple, gentle approach – what they call "relaxing touch" – can make a positive difference for patients who are seriously ill. When patients are very unwell and need help breathing, doctors often give them medicines to keep them calm and comfortable. This is called sedation, and it means they are not fully awake.

The main idea behind this study is to see if regular, gentle touch can help patients reduce the amount of calming medicine they need as they start to wake up and get ready to have their breathing tube taken out. The research team wants to ensure patients are as comfortable as possible during this important time. If relaxing touch can help, it might mean patients need less strong medication, which could lead to a smoother recovery in intensive care.

The study will involve some patients receiving this relaxing touch on their hands, feet, or head for 30 minutes, twice a day. Doctors will then compare how these patients recover compared to those who receive the usual care. They hope to learn if this gentle approach can help patients feel less anxious and rely less on medication while in the intensive care unit.

Key takeaways

This study is about helping intensive care patients feel more comfortable.
It tests if gentle, relaxing touch can reduce the need for strong calming medicines.
Participation involves receiving touch on hands, feet, or head twice daily for 30 minutes.
All participants receive standard medical care; the touch is an extra intervention.
The goal is to make recovery and removal of breathing tubes smoother.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or over. You must be receiving care in the intensive care unit at Niort Hospital, be on a breathing machine, and receiving calming medicines. There's also a specific timeframe for how long you've been on the breathing machine and when it's expected to be removed.

Someone close to you, like a family member or a legal representative, would need to agree to your participation on your behalf, as you might not be fully awake to do so yourself. You also need to be part of the social security system in France.

However, you wouldn't be able to join if you are pregnant, have certain skin conditions on your hands, feet, or head, or if you're already taking long-term antidepressant medication. Also, if you're involved in another medical study, are under guardianship, in prison, or if you or your representative decide later not to participate, you would not be included.

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 an adult (18 years or older)?
Are you in intensive care at Niort Hospital, on a breathing machine?
Do you have a family member or legal representative who can agree for you?
Do you NOT have skin wounds on your hands, feet, or head?
Are you NOT taking long-term antidepressant medicines or pregnant?
Are you NOT already in another medical study?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, or your representative agrees for you, you would be assigned by chance (like flipping a coin) to one of two groups. One group would receive standard intensive care. The other group would receive an additional treatment: a nurse or trained professional would provide gentle, relaxing touch on your hands, feet, or head. This touch would last for 30 minutes and happen twice a day. This would continue from the point when your calming medicines are started to be reduced until your breathing tube is removed. There are no additional medications or difficult tests involved, only the observation of how well you cope with the relaxing touch compared to standard care. The total duration of your participation would depend on how long you remain in intensive care and need a breathing tube.

Potential risks and benefits

The potential benefits of this study include the possibility that receiving relaxing touch could help you feel calmer and reduce your need for strong calming medicines, potentially leading to a smoother recovery. There are very few known risks associated with gentle touch; however, if you have sensitive skin or any discomfort, the touch would be stopped. You, or your representative, have the right to withdraw from the study at any time without giving a reason, and this would not affect your medical care.

Locations (1)

Centre Hospitalier de Niort
Verified postcode
Niort, France· Recruiting

Common questions

What is 'relaxing touch'?

Relaxing touch is a gentle way of touching someone's hands, feet, or head, designed to help them feel calm and comfortable.

Why is this study important?

It's important because it aims to find out if simple, gentle methods can help intensive care patients feel better and potentially reduce the amount of strong medicine they need.

Will I still get my usual medical care?

Yes, all patients in the study will still receive the full standard medical care that is best for their condition. The relaxing touch is an extra potential therapy.

What if I feel uncomfortable during the touch?

If you are able to communicate, or if medical staff observe any discomfort, the relaxing touch would be immediately stopped.

Who will provide the relaxing touch?

The relaxing touch will be provided by a nurse or another trained professional at the hospital.

How to find out more

Jean Marc M. Le Guevel, Nurse coordinator

jean-marc.leguevel@ch-niort.fr 549783254 Official trial record

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