Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery
This study aims to find out if a gentle skin stimulation technique, called Cutaneous Resonance Stimulation (RESC), can help calm down patients who are feeling anxious before heart surgery. It's common to feel stressed before a big operation, and high anxiety can sometimes lead to more pain or problems afterwards. While medications used to calm nerves before surgery aren't always effective, researchers are looking for new ways to help. This study will compare the RESC technique to a sham stimulation (a fake treatment) to see if RESC can help balance the body's natural stress response and reduce anxiety levels, potentially making the surgical experience smoother for patients.
At a glance
What is this study about?
Imagine you're about to have an important heart operation. It's completely normal to feel worried or anxious – in fact, most people do! This feeling often peaks just before the surgery itself. While doctors used to give calming medicines for this, they don't always work as well as hoped, and sometimes new approaches are needed.
Our bodies have an amazing system called the autonomic nervous system. Think of it like a control panel that handles things we don't consciously think about, like our breathing, heart rate, and how we react to stress. It has two main parts: one that revs us up (like a sympathetic 'fight or flight' response) and another that calms us down (a parasympathetic 'rest and digest' response). When you're anxious, the 'rev-up' part might be working overtime. Other calming techniques like massage or relaxation seem to help by gentle nudging this balance.
This study is testing a specific type of gentle skin stimulation called Cutaneous Resonance Stimulation, or RESC for short. The idea is that by gently stimulating certain points on the skin, it might help to rebalance this autonomic nervous system, making the 'calm down' part work a bit better and reducing overall anxiety. We want to see if a session of this RESC technique before heart surgery can make patients feel less anxious compared to a fake stimulation, which helps us understand if the real technique is truly effective.
Key takeaways
- The study explores a gentle skin stimulation (RESC) for pre-surgery anxiety.
- It aims to balance the body's natural stress response.
- Participants will receive either RESC or a sham treatment before heart surgery.
- Anxiety levels will be measured using questionnaires and heart rate.
- Participation involves a single session; no long-term follow-up.
Who may be eligible?
To be part of this study, you need to be an adult (18 years or older) who is scheduled for heart surgery that involves using a heart-lung machine during the operation. We're specifically looking for people who are feeling a certain level of anxiety before their surgery; this will be checked using a simple questionnaire or scale.
There are some reasons why you wouldn't be able to join. If your surgery is an emergency, you wouldn't be eligible. Also, if you have a specific type of irregular heartbeat called atrial fibrillation, or if you can't complete the anxiety questionnaires, you won't be able to take part. We also can't include you if you're already using other specific alternative methods to manage your anxiety before the study, or if you are pregnant or breastfeeding.
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 scheduled for heart surgery that uses a heart-lung machine?
- Are you currently feeling anxious about your upcoming surgery?
- Is your surgery not an emergency?
- Do you not have atrial fibrillation (a specific type of irregular heartbeat)?
- Are you able to answer questionnaires about how you feel?
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either the RESC skin stimulation or a sham (fake) stimulation, meaning you won't know which one you're getting. Both groups will have one session of this stimulation shortly before your heart surgery. We will check your anxiety levels using simple questionnaires or scales before and after the session, and we'll also measure your heart rate to understand your body's stress response. This is a one-time intervention before your surgery, and there will be no long-term follow-up as part of this specific study.
Potential risks and benefits
Locations (1)
- Hopitallouis PradelVerified postcodeBron, France· Recruiting
Common questions
What is 'heart surgery with extracorporeal circulation'?
This means you're having heart surgery where a heart-lung machine temporarily takes over the job of your heart and lungs, allowing surgeons to work on your heart.
What is RESC?
RESC stands for Cutaneous Resonance Stimulation. It's a gentle, hands-on technique that involves stimulating specific points on your skin to try and help balance your body's stress response.
Will I know if I'm getting the real treatment or the fake one?
No, this is a 'single-blind' study, meaning you won't know if you're getting the actual RESC treatment or the sham (fake) stimulation. This helps ensure the results are unbiased.
How will my anxiety be measured?
Your anxiety levels will be measured using questionnaires or simple scales where you rate how you feel, and also by looking at your heart rate patterns.
How long does taking part last?
Your participation in the study involves one session of stimulation and a few quick anxiety measurements just before your heart surgery. There's no long-term follow-up for this study.
How to find out more
CHARRION Chantal
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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