Description

INTRODUCTION Undergoing clinical and care procedures is inherently a source of stress for patients. Further, feelings of discomfort, anger, and depression can influence the patient's overall experience, often in association with emotional states such as fear, tension, and nervousness.

Anxiety, for example, is an emotional adaptive response to stimuli perceived by humans as threatening (stressors). In normal conditions, it supports environmental adaptation to avoid or confront danger. However, when the response to the stimulus is excessive and disproportionate, it can become pathological. This reaction may arise in response to trauma-related triggers or specific situations in which not all elements are fully understood. Acute preoperative anxiety may vary depending on patient characteristics, the type of surgery, or other external circumstances. High levels of preoperative anxiety are associated with negative psychological conditions and somatic effects that may impact anesthesia, surgical outcomes, and rehabilitation. Preoperative anxiety is common among surgical patients and has been widely documented in the literature. From an anesthesiological perspective, the relationship between anxiety and sedation effectiveness is inverse. Notable consequences may include increased pharmacological induction requirements, intraoperative hemodynamic instability, higher consumption of analgesics, prolonged anesthetic recovery, higher rates of postoperative pain, increased morbidity and mortality, patient dissatisfaction with hospitalization, and extended length of stay. This highlights how the perioperative pathway can be highly stressful and anxiety-inducing, starting from the preoperative phase.

Another factor influencing the patient's experience and potentially contributing to distress is pain. Despite the clinical, psychological, and cultural factors known to contribute to the onset of post-surgical, chronic, or post-procedural pain, its management remains a challenge and a priority.

This premise emphasizes the need to implement care strategies aimed at limiting negative emotions, with the goal of preventing and minimizing adverse events during surgery and the postoperative recovery. Various studies have documented the positive effects of care interventions in reducing anxiety and pain, such as music therapy, art therapy, or play therapy. Among these, hypnotic communication is also reported in the literature.

Hypnosis is an altered state of consciousness in which psychological and somatic modifications may occur.

Hypnotic communication involves the delivery of suggestions to the patient without formal hypnotic induction, within a relational context characterized by empathy and trust. It is a communication technique that consciously applies neurolinguistic mechanisms related to certain mental functions. The core principle of hypnotic communication is the awareness of the power of words to generate mental imagery, which resonates in the body and induces changes.

One of its earliest uses in healthcare was in anesthesiology, even before the introduction of ether. Over time, it has been employed in surgical preparation to help patients experience less anxiety and pain, resulting in reduced pharmacological needs and improved postoperative recovery. The literature documents the use of hypnotic communication in routine care procedures, such as peripheral venous catheter (PVC) insertion and PICC placement, as well as in cardiology settings prior to invasive procedures, such as transcatheter ablation in atrial fibrillation and S-ICD implantation. The positive impact of hypnotic communication on patients includes both emotional (anxiety) and pain dimensions, leading to reduced use of analgesic-sedative drugs due to the synergistic effect between hypnotic communication and pharmacological therapy. Previous studies have suggested a possible alteration in patients' perception of procedural duration. Importantly, hypnotic communication has not been found to compromise procedural safety or success rates. A potential limitation in the implementation of hypnotic techniques may be patients' individual predisposition to hypnosis, which can be influenced by personality traits-e.g., highly controlled behaviors may hinder rapport with the operator.

While the positive aspects of hypnotic communication are evident, the literature highlights the need for further methodologically rigorous studies to provide additional evidence regarding the safety and efficacy of this method.

OBJECTIVE OF THE STUDY To evaluate the effectiveness of hypnotic communication in reducing emotional distress (stress, anxiety, depression, anger, and need for help) in patients undergoing elective coronary angiography.

METHODS Study Design This is an open-label, randomized controlled trial with a 1:1 allocation ratio.

Study Setting The study, promoted by the University of Eastern Piedmont (UPO) and coordinated by the Health Professions Direction at the Biella Local Health Authority (ASL Biella), will be conducted in the Cardiology Unit of the Ospedale degli Infermi in Ponderano (ASL Biella).

Eligibility Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• Cognitive impairment or neurodegenerative disorders that may compromise the ability to provide informed consent;
• Psychiatric disorders, neurodegenerative diseases, or major depressive states.

Intervention

Experimental Group In addition to standard care, a session of hypnotic communication will be initiated prior to the coronary angiography.

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.

Hypnotic communication follows a process consisting of five distinct phases:

1. Pre-induction
2. Induction
3. Core (Body)
4. De-induction
5. Closure (Tail)

The session will be discontinued if the patient withdraws consent or reports discomfort at any point.

Control Group Patients in the control group will receive standard of care only. OUTCOMES

Primary Outcome:

Emotional state (stress, anxiety, depression, anger, and need for help), assessed using the Italian version of the Emotion Thermometer Tool, a tool previously used in Italian clinical settings.

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.

The assessment will be conducted in the patient's room before preparation for the operating room and will be repeated at the end of the cardiologic procedure.

Secondary Outcomes:

• Pain, assessed with NRS at 15 and 60 minutes post-procedure;
• Satisfaction with hypnotic communication (experimental group only), assessed using a 0-5 Likert scale.

SAMPLE SIZE Assuming a type I error (α) of 0.05 and a power of 80%, and considering a standard deviation of the change in patients' emotional state between the beginning and the end of the procedure of 11.43 in the group receiving hypnotic communication and 6.56 in the control group, a total of 306 subjects (153 per group) will be required to detect a pre-post intervention difference of 3.

RECRUITMENT Patients will be recruited during hospitalization. The estimated recruitment period is 24 months, assuming a 90% enrollment rate of the patients scheduled weekly for elective coronary angiography.

ALLOCATION Randomization based on a randomization list, will use sealed opaque envelopes. Patients may be withdrawn due to consent withdrawal or significant intraoperative changes.

BLINDING Not applicable (open-label design). DATA COLLECTION, MANAGEMENT, AND ANALYSIS Data will be collected in four phases: enrollment, pre-intervention, intervention, and post-intervention. Outcomes will be analyzed using ITT principles, with appropriate statistical tests and mixed models if needed. Significance will be set at p \< 0.05.

ETHICAL ASPECTS AND DISSEMINATION Ethical approval will be obtained. All data will be anonymized and securely stored. The study will be published regardless of outcomes.

INFORMED CONSENT Obtained by trained nurses through both oral explanation and written documentation. Consent for data processing will also be obtained.

CONFIDENTIALITY Patients will be identified by an alphanumeric code. No personally identifiable information will be recorded.