The Effectiveness of Hypnotic Communication in Reducing Emotional Distress and Improving Patient Experience During Elective Coronary Angiography: A Monocentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Emotional state (stress, anxiety, depression, anger, and need for help), assessed with the Italian version of the Emotion Thermometer Tool
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Cognitive impairment or neurodegenerative disorders that may compromise the ability to provide informed consent;
- •Psychiatric disorders, neurodegenerative diseases, or major depressive states.
研究组 & 干预措施
Hypnotic Communication
In the intervention group, adult patients (≥18 years), of both sexes, referred to the Cardiology Unit and scheduled for elective coronary angiography, who are able to read and understand Italian, will receive a session of hypnotic communication in addition to standard care.
This session will be conducted by nursing staff trained in hypnotic communication. It will begin at the patient's bedside before the procedure and continue throughout the coronary angiography, ending when the procedure is complete. The communication technique follows a structured five-phase model: pre-induction, induction, core (body), de-induction, and closure (tail). It uses empathetic, suggestive language without formal hypnosis, aiming to reduce emotional distress (such as anxiety, stress, and fear) and improve the overall patient experience.
Patients may withdraw from the session at any time if they feel discomfort or no longer wish to participate.
干预措施: Hypnotic Communication (Other)
Control group
Patients in the control group will receive standard of care only.
结局指标
主要结局
Emotional state (stress, anxiety, depression, anger, and need for help), assessed with the Italian version of the Emotion Thermometer Tool
时间窗: Immediately before preparation for transfer to the hemodynamics laboratory and 60 minutes after completion of the coronary angiography procedure.
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.
次要结局
- Pain, assessed with NRS(At 15 and 60 minutes post-procedure)
- Level of patient's satisfaction(Within 60 minutes after completion of the coronary angiography procedure.)