Hypnotic Communication in Cardiology: A Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi del Piemonte Orientale Amedeo Avogadro

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years), of both sexes, referred to the Cardiology Unit and scheduled for elective coronary angiography;

Ability to read and understand the Italian language.

Disqualifiers

Cognitive impairment or neurodegenerative disorders that may compromise the ability to provide informed consent;

Psychiatric disorders, neurodegenerative diseases, or major depressive states.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypnotic Communication

    Other intervention

    Hypnotic communication follows a process consisting of five distinct phases (Granone, 1989): 1. Pre-induction 2. Induction 3. Core (Body) 4. De-induction 5. Closure (Tail) The intervention will be delivered by nursing staff trained and experienced in hypnotic communication. The session will begin at the patient's bedside and continue throughout the entire procedure, concluding upon its completion.

Treatment groups

306 Participants
are divided into 2 treatment groups
Group A: Hypnotic CommunicationExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Emotional state (stress, anxiety, depression, anger, and need for help), assessed with the Italian version of the Emotion Thermometer Tool

Emotional state (stress, anxiety, depression, anger, and need for help), assessed using the Italian version of the Emotion Thermometer Tool. This is a visual-analogue scale that evaluates the combination of five emotional dimensions: * Stress * Anxiety * Depression * Anger * Need help Each dimension is scored on a scale from 0 to 10, where 0 indicates "not at all" and 10 indicates "extremely." For individual items, scores from 0 to 3 are considered low, while scores from 4 to 10 are considered high. As for the total score of the scale, a score between 9 and 14 is considered mild, 15 to 20 is moderate, and scores above 20 are considered severe.

Time frame
Immediately before preparation for transfer to the hemodynamics laboratory and 60 minutes after completion of the coronary angiography procedure.

Secondary outcomes

1

Pain, assessed with NRS

Pain will be assessed with NRS at 15 and 60 minutes post-procedure.

Time frame
At 15 and 60 minutes post-procedure
2

Level of patient's satisfaction

Satisfaction with hypnotic communication (experimental group only), assessed using a 0-5 Likert scale.

Time frame
Within 60 minutes after completion of the coronary angiography procedure.

Other outcomes

Sponsors and contacts

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