Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Efficacity of hypnosis versus premedication for the management of perioperative anxiety in gynecological surgery

This research study is investigating how well hypnosis works compared to standard calming medicines given before gynaecological surgery. The main goal is to see if hypnosis can help women feel less anxious and more comfortable before their operation. Doctors want to understand if this gentler approach can be just as effective, or even more so, in managing pre-surgery nerves. The study is open to adult women and is in its final stages, meaning the treatment is already used, and researchers are gathering more information about its everyday benefits. By taking part, you could help improve how future patients are supported before their surgery, making the experience smoother and less stressful for many.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

CHRU De Nancy

Enrolment target

128

Start

26 Jul 2024

perioperative anxiety

What is this study about?

Imagine you're having an operation, and it's completely normal to feel a bit nervous or anxious beforehand. This study is all about finding the best way to help women feel more relaxed before gynaecological surgery. Usually, doctors might give you some medicine to help you calm down. This study is exploring if a technique called hypnosis could be another good option, or even a better one, to ease those pre-surgery worries.

Hypnosis, in this context, is a focused and relaxed state where you're very open to suggestions that can help you feel calm and comfortable. It's not about losing control; you're fully aware of what's happening. Researchers want to compare it directly with the calming medicines often used, to see which method helps patients feel more at ease before their operation. This is important because feeling less anxious before surgery can often lead to a smoother recovery.

This particular study is in its final phase, which means the general use of this approach is already known to be safe. Now, researchers are looking closely at how effective it is in real-world settings. By taking part, you wouldn't just be helping yourself, but you'd also be contributing valuable information that could improve how all women are cared for before gynaecological surgery in the future, making their experience much more comfortable.

Key takeaways

Compares hypnosis to calming medicines for pre-surgery anxiety.
Aims to make gynaecological surgery less stressful for women.
Open to adult women (18+ years old).
Hypnosis is generally a safe and relaxing technique.
You can stop participating at any time.
Could help improve future patient care.

Who may be eligible?

This study is particularly looking for women who are at least 18 years old and are scheduled for gynaecological surgery. To be considered, you'll need to be an adult, as the study focuses on adult experiences.

There aren't many other specific details provided about who can or cannot join, but generally, you'd need to be healthy enough for gynaecological surgery. The research team will speak with you to understand your health history and ensure this study is a good fit for you.

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 a woman?
Are you scheduled for gynaecological surgery?
Are you generally well enough for surgery?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main involvement would be receiving either hypnosis or standard calming medication before your gynaecological surgery. You would attend your scheduled surgery appointment as planned. Before your operation, you would either have a session with a hypnotherapist or receive the usual pre-surgery calming medicines. The research team would then monitor your anxiety levels using simple, short questionnaires. After your surgery, there might be a follow-up to see how you felt overall. The total duration of your active involvement would primarily be around the time of your surgery, with possibly one or two brief follow-ups. You would continue to receive all the standard care for your surgery as well.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as experiencing reduced anxiety before your surgery, whether through hypnosis or the standard calming medication. This could make your surgical experience feel more comfortable for you. However, as with any medical treatment or research, there are potential risks, though not specified for this study. Hypnosis is generally considered very safe, and calming medications have known side effects, which your doctor would discuss. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is gynaecological surgery?

Gynaecological surgery refers to operations performed on a woman's reproductive system, such as the uterus, ovaries, or fallopian tubes.

What is 'perioperative anxiety'?

This is simply the worry or nervousness you might feel around the time of an operation, including before, during, and immediately after surgery.

Is hypnosis safe?

Hypnosis, when used by a trained professional, is generally considered a safe and relaxing technique, where you remain aware and in control.

Will I be awake during hypnosis?

Yes, you remain fully awake and aware during hypnosis. It's a state of focused attention and deep relaxation, not sleep or unconsciousness.

What are 'premedication' medicines?

These are medicines given before surgery, often to help you relax, reduce anxiety, or sometimes to help with pain or nausea.