What this Trial Is About

Undergoing medical procedures, especially surgical ones, is a significant source of emotional stress for patients. Emotions like anxiety, fear, anger, and depression often accompany such experiences and can negatively impact clinical outcomes. Preoperative anxiety, in particular, affects nearly half of all surgical patients and can lead to complications such as hemodynamic instability, increased medication needs, and prolonged recovery times. Managing this emotional distress is therefore a priority. While pharmacological strategies are commonly used, growing attention is being given to non-drug interventions such as music, art, and play therapies. One such technique is hypnotic communication-a method that uses empathetic, suggestion-based language to influence emotional and physical states without formal hypnotic induction. This technique has roots in anesthesiology and has shown promise in reducing pain and anxiety during medical procedures. The proposed study aims to evaluate the effectiveness of hypnotic communication in reducing emotional distress in patients undergoing elective coronary angiography. This will be done through a randomized controlled trial involving 306 adult patients at the Cardiology Unit of the Ospedale degli Infermi in Biella, Italy. Participants will be randomly assigned to either an experimental group receiving hypnotic communication alongside standard care, or a control group receiving standard care only. The hypnotic session, delivered by trained nurses, will begin before the procedure and continue until it ends, following a five-phase structure (pre-induction, induction, core, de-induction, and closure). The primary outcome is the patient's emotional state-specifically stress, anxiety, depression, anger, and need for help-measured before and after the procedure using the Emotion Thermometer Tool. Secondary outcomes include post-procedural pain (measured 15 and 60 minutes after) and patient satisfaction with the communication technique. The study is designed with a type I error rate of 0.05 and 80% statistical power, and recruitment is expected to last 24 months. Data will be anonymized, securely stored, and analyzed using appropriate statistical methods. Ethical approval and informed consent are integral parts of the protocol. By investigating the emotional and clinical impact of hypnotic communication, the study hopes to support its integration into routine care practices, offering a simple, safe, and cost-effective method to enhance patient well-being during invasive procedures.

Hypnotic Communication in Cardiology: A Randomized Controlled Trial