RecruitingNAINTERVENTIONAL

Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery

This research wants to find out the best way to help patients stay relaxed and calm during hand surgery. Doctors usually use local numbing medicine for the hand, and this study is comparing two ways to help with anxiety on top of that. One way is called 'neuroleptanalgesia,' which involves giving medicines that make you feel calm and less aware. The other way is 'hypnoanalgesia,' which uses hypnosis to help you manage pain and stay relaxed. Researchers will look at how anxious patients feel before and during the surgery, and also compare pain levels, how long surgery takes, and how happy patients are with their experience. Everyone in the study will be having a basic hand operation as an outpatient.

At a glance

Status

Recruiting

Phase

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

Start

19 Oct 2023

Estimated completion

01 Jan 2027

Hand Surgery

What is this study about?

Imagine you're having a small operation on your hand, like for carpal tunnel syndrome, where they just numb your hand. Even with a numb hand, some people can still feel a bit anxious or nervous during surgery. This study aims to find the best way to help you stay calm and comfortable during the whole process.

Researchers are comparing two main approaches. The first approach uses specific calming medicines given during the surgery. This is meant to help you relax and feel less aware of what's happening. The second approach uses a technique called hypnotherapy. Hypnosis can help you focus your mind and manage discomfort or anxiety without necessarily needing lots of extra medication.

The main goal is to see which of these two methods is better at reducing anxiety during your hand surgery. They will ask you about your anxiety levels before and after the surgery. They'll also check other things like how much pain you feel, how long the surgery lasts, and how satisfied you are with your care. The results could help doctors decide the best ways to keep patients comfortable and happy during these types of operations in the future.

Key takeaways

Compares two ways to reduce anxiety during hand surgery: calming medicines vs. hypnotherapy.
Aims to find out which method helps patients feel most relaxed and comfortable.
You'll still receive local numbing for your hand.
Study is for common outpatient hand operations.
Participation involves monitoring your comfort and anxiety on the day of surgery.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 80 years old. You must be planned for a common type of outpatient hand surgery, like for carpal tunnel, where only your arm or hand is numbed, and you'd normally receive some kind of sedation to help you relax. You'll also need to read and sign a consent form, showing you understand the study and agree to take part after you've had some time to think about it.

There are some reasons why you wouldn't be able to join. For example, if you can't have the numbing medicine or certain calming drugs, or if you are pregnant, breastfeeding, or a woman who could become pregnant and isn't using reliable contraception. Also, if you have conditions that make it hard to understand and agree to the study, such as dementia or severe confusion, or if you don't speak French, you won't be able to participate. This study is taking place in France, so being part of their social security system is also a requirement.

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 between 18 and 80 years old?
Are you having a hand surgery as an outpatient, like for carpal tunnel?
Are you able to read and understand information about the study?
Are you not pregnant or breastfeeding, and using reliable contraception if you could get pregnant?
Do you not have any issues that prevent you from having the numbing medicine or certain calming drugs?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be involved on the day of your hand surgery. Before your operation, you would be assigned to one of two groups: one receiving calming medication or one receiving hypnotherapy, in addition to your local numbing injection. During the surgery, the study team would be observing how you respond and asking you about your anxiety levels. They'll also record information about your pain, how long the surgery takes, and your overall satisfaction. There won't be many extra visits or long-term follow-up beyond your usual surgical care.

Potential risks and benefits

Participating in this study might offer you the benefit of potentially feeling more comfortable and less anxious during your hand surgery, contributing to a more positive experience. There are some potential risks associated with the calming medications, such as feeling drowsy or experiencing other side effects, which your medical team will discuss with you. Hypnotherapy is generally very safe, but its effectiveness can vary from person to person. You have the full right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hôpital Privé Paul d'Egine
Verified postcode
Champigny-sur-Marne, France· Recruiting

Common questions

What is the main purpose of this study?

It's comparing calming medicines with hypnotherapy to see which is better at reducing anxiety during hand surgery.

Will I still get anaesthesia for my hand?

Yes, you will still get the local numbing injection for your hand as usual.

Do I have to do anything special before the surgery?

You'll just need to read and sign a consent form after understanding the study details.

What happens if I don't like being in the study?

You can leave the study at any time, and it won't affect your medical care.

Who is paying for this study?

The information provided doesn't state who is funding the study.

How to find out more

Mélanie FROMENTIN, MD

mfromentin.anesthesierea@gmail.com 01 86 86 66 00 Official trial record

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